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by Steven Niles Acanya Gel (acanyagel.com) Acanya Gel is the only FDA-approved fixed combination antibiotic and benzoyl peroxide medication for once daily treatment of both non-inflammatory and inflammatory lesions of acne. The product is indicated for the once-daily treatment of acne vulgaris in patients 12 years and older. Formulated in an aqueous-based, alcohol-free gel, Acanya was optimized to provide enhanced bioavailability of benzoyl peroxide. Accretropin Injection Accretropin Injection is indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed. Cangene’s recombinant human growth hormone is identical in sequence to authentic human growth hormone of pituitary origin. Natural human growth hormone is a protein produced by the pituitary gland that acts on the ends of the long bones of the body until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature. AdreView AdreView is a molecular imaging agent for the detection of rare neuroendocrine tumors in children and adults. The product provides high quality images that allow physicians to detect tumors, both at the time of initial diagnosis and at later examinations when relapse or recurrence is suspected. Neuroblastoma is the most common extra-cranial solid tumor of young children up to 5 years old, while pheochromocytoma is a rare tumor typically affecting adults. Both tumors usually arise from tissues of the sympathetic nervous system, most commonly in the adrenal glands. Neuroblastoma and pheochromocytoma can be difficult to detect at an early stage because symptoms may be non-specific when the tumors are small. AdreView images reflect the functional behavior of the tumor cells, thus allowing clearer characterization of even small tumors in comparison with similar appearing but non-malignant tissues. AdreView provides adjunctive information to complement anatomic imaging procedures such as CT and MRI. AK-Fluor AK-Fluor is approved for use in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Akten Ophthalmic Gel 3.5% Akten is the first new drug applcation for an ocular anesthetic approved by FDA in four decades. Akten is a novel, unit dose, preservative free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent. The estimated market size for Akten is about 11 million procedures annually. The major procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection. Aloxi Capsules 0.5 milligrams Aloxi Capsules 0.5 milligrams for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5-milligram Aloxi Capsule is administered about one hour prior to the start of chemotherapy. Aloxi injection 0.25 milligrams, a 5-hydroxytryptamine-3 receptor antagonist, has been available in the United States for intravenous administration since 2003 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy. A single 0.25-milligram intravenous dose of Aloxi is administered about 30 minutes before the start of chemotherapy. Alvesco Alvesco Inhalation Aerosol is a new generation of inhaled corticosteroid that reduces inflammatory processes and is indicated for the maintenance treatment of asthma as prophylactic therapy in adult patients 12 years old and older. Alvesco is based on the active ingredient ciclesonide, which is Nycomed’s patented corticosteroid with a novel principle of action. Ciclesonide is a prodrug that is activated by intracellular esterases following oral inhalation. Alvesco has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response. Aplenzin Aplenzin is a once-daily formulation of bupropion developed by Biovail for the treatment of depression in adults. The product is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174-milligram, 348-milligram, and 522-milligram extended-release tablets. The 522-milligram dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option. Apriso Apriso is the first and only mesalamine product approved by FDA for once-a-day dosing for the maintenance of remission of ulcerative colitis. Additionally, the locally-acting aminosalicylate is the first and only 5-ASA with Intellicor extended release delivery technology. Apriso combines an enteric pH-dependent coating that provides for a delayed release starting at a pH of 6.0 and a polymer matrix core, which provides for extended release. This patented delivery technology is designed to distribute the active ingredient beginning in the small bowel and continuing throughout the colon. Previous generation pH-dependent 5-ASA treatment options provide for release of the active ingredient starting at a pH of 7.0. According to published data, many people never reach a pH of 7.0 in their small or large intestine. Aptivus Oral Solution Aptivus Oral Solution, co-administered with ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected pediatric patients 2 years old to 18 years old who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. FDA granted full approval to Aptivus capsules for treatment-experienced adults in October 2007. Arcalyst Arcalyst is indicated for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome in adults and children 12 and older. Arcalyst is a targeted inhibitor of interleukin-1, the key driver of inflammation in cryopyrin-associated periodic syndromes. Artiss Artiss is the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. Artiss was developed using Baxter’s fibrin sealant technology platform. Artiss allows for the delayed setting and controlled manipulation of skin grafts for about 60 seconds, relative to rapid-setting fibrin sealants, which set in five seconds to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. Astepro Nasal Spray Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active substance in these products is azelastine, the leading nasal antihistamine in the treatment of rhinitis in the United States. Astepro is now approved for the treatment of seasonal allergic rhinitis. Fewer reports of bitter taste and nasal discomfort were recorded by Astepro users, and the product was in general better tolerated than Astelin. Symptom relief, as recorded by patients, was also better. In total, about 1,400 patients were involved in Meda’s Phase III studies. Banzel Banzel is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years old and older and adults. One of the most severe forms of childhood epilepsy, Lennox-Gastaut syndrome is characterized by multiple and frequent seizures. Eisai received a complete response letter for Banzel as an adjunctive treatment for partial-onset seizures with and without secondary generalization in adults and adolescents 12 years old and older. Banzel is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs. The drug is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures. Cefepime Injection in Galaxy Container Cefepime Injection in Galaxy Container is indicated as empiric therapy for the treatment of febrile neutropenia; for the treatment of complicated intra-abdominal infections; for the treatment of pneumonia; for the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis); and for the treatment of uncomplicated skin and skin structure infections. Cimzia Cimzia is the first and only PEGylated anti-Tumor Necrosis Factor alpha antibody indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. PEGylation technology was designed by Enzon Pharmaceuticals Inc. (enzon.com) to improve versions of injectable therapeutics through the chemical attachment of polyethylene glycol or PEG. Cinryze Cinryze is the first and only FDA-approved C1 inhibitor therapy for routine prophylaxis against hereditary angioedema attacks in the United States. Cinryze is indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema, also known as C1 inhibitor deficiency. July 15, 2008, Cinryze developer Lev Pharmaceuticals and ViroPharma signed a definitive merger agreement under which ViroPharma acquired Lev. Cleviprex Cleviprex is approved for the reduction of blood pressure when oral therapy is not feasible or not desirable. A novel IV antihypertensive, Cleviprex represents an advancement over other approved drugs, providing rapid and precise control of blood pressure in the critical care setting. Cleviprex has a rapid onset and offset of action and can be titrated for precise blood pressure control. Unlike many current IV antihypertensive agents, which are metabolized by the kidney and/or liver, Cleviprex is metabolized in the blood and tissues and does not accumulate in the body. Cosyntropin Cosyntropin is indicated for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Desmopressin acetate Desmopressin acetate tablets are approved as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. The product is also approved for the management of primary nocturnal enuresis and to determine the capacity of the kidney to concentrate urine in pediatric patients. Degarelix Degarelix represents Ferring’s first global product launch. A new injectable gonadotropin-releasing hormone receptor antagonist, degarelix is indicated for patients with advanced prostate cancer. Potential trade names are still under review with FDA. Following issuance of a trade name, Ferring will immediately begin commercialization in the United States. Dec. 18, the Committee for Medicinal Products for Human Use, part of the European Medicines Agency, recommended granting a marketing authorization for degarelix in Europe. Degarelix is awaiting approval in other key global markets. Durezol Durezol is a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review. Durezol is Sirion’s first product to be approved by FDA. Durezol is a difluorinated derivative of prednisolone and has potent anti-inflammatory activity. Emend for Injection (emend.com) Emend for Injection provides a new option for patients receiving an antiemetic on day one of their chemotherapy. Emend for Injection may be substituted for the 125-milligram oral capsule of Emend on day one and is administered 30 minutes prior to the initiation of chemotherapy during a 15-minute period. Emend and Emend for Injection belong to a class of medications called substance P/neurokinin 1 receptor antagonists and are believed to work through a novel mechanism, which primarily blocks nausea and vomiting signals to the brain. Emend oral capsules are recommended as one part of standard antiemetic regimens to prevent the acute or delayed nausea and vomiting caused by specified chemotherapies by major clinical oncology treatment guidelines. Entereg (entereg.com) Entereg capsules are approved to help patients regain gastrointestinal function earlier following bowel resection surgery. Postoperative ileus is a condition that affects almost all patients undergoing this type of surgery and can cause significant discomfort in addition to prolonging hospital stays for patients. Entereg is indicated to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Entereg is available for short-term use in hospitals registered under the Entereg Access Support and Education program. Entereg is a peripherally acting mu-opioid receptor antagonist. Opioid analgesics, such as morphine, are widely used for the treatment of postoperative pain. Entereg works by binding to mu-opioid receptors in the gut, thereby selectively inhibiting the negative effects of opioid medications on gastrointestinal function and motility. Eovist Eovist is the first organ-specific MRI contrast agent approved in the United States in more than a decade. A gadolinium-based contrast agent, Eovist is approved for intravenous use in T1-weighted magnetic resonance imaging of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. Eovist is a paramagnetic MRI contrast agent that combines features of both an extracellular contrast agent and a hepatocyte-specific agent. Eovist is administered via an intravenous, bolus injection and has a dual route of excretion with about 50% eliminated through the liver and 50% eliminated through the kidney. Detection and characterization of malignant and benign focal liver lesions with Eovist may help enhance diagnostic accuracy and increase diagnostic confidence. Epiduo Epiduo is indicated for the topical treatment of acne vulgaris in patients 12 years old and older. Epoprostenol for Injection 1.5 milligrams Epoprostenol for Injection 1.5 milligrams is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. Epoprostenol for Injection is available in 10 milliliter vials containing lyophilized epoprostenol sodium equivalent to 1.5 milligrams of epoprostenol. When reconstituted and diluted for administration with Water for Injection or Sodium Chloride Injection, the infusion solution is stable for up to 24 hours at room temperature. GeneraMedix’s product differs from other available epoprostenol formulations, which require a special diluent and gel packs in a cold pouch in order to maintain stability for 24 hours. Flo-Pred Flo-Pred is indicated for the control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediatric populations with atopic dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, and serum sickness. Flo-Pred is indicated for the treatment of conditions related to organ transplantations such as acute or chronic solid organ rejection. Flo-Pred is indicated for the treatment of dermatologic diseases such as bullous dermatitis herpetiformis, contact dermatitis, exfoliative erythroderma, mycosis fungoides,pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Flo-Pred is indicated for the treatment of endocrine conditions such as congenital adrenal hyperplasia,nonsuppurative thyroiditis, primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable. Flo-Pred is indicated for the treatment of gastrointestinal diseases during acute episodes of Crohn disease and ulcerative colitis. Flo-Pred is indicated for the treatment of hematologic diseases such as acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia,Idiopathic thrombocytopenic purpura in adults, Pure red cell aplasia, and secondary thrombocytopenia in adults. Flo-Pred is indicated for the treatment of neoplastic conditions such as acute leukemia and aggressive lymphomas. Flo-Pred is indicated for the treatment of nervous system conditions such as acute exacerbations of multiple sclerosis and cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury. Flo-Pred is indicated for the treatment of ophthalmic conditions such as sympatheitic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical steroids. Flo-Pred is indicated for the treatment of pulmonary diseases such as acute exacerbations of chronic obstructive pulmonary disease, allergic bronchopulmonary aspergillosis, aspiration pneumonitis, asthma,fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy, hypersensitivity pneumonitis, idiopathic bronchiolitis obliterans with organizing pneumonia, idiopathic eosinophilic pneumonias, idiopathic pulmonary fibrosis, pneumocystis carinii pneumonia associated with hypoxemia occurring in an HIV(+) individual who is also under treatment with appropriate anti-PCP antibiotics, and symptomatic sarcoidosis. Flo-Pred is indicated for the treatment of renal conditions such as to induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Flo-Pred is indicated for the treatment of rheumatologic conditions during an exacerbation or as maintenance therapy in selected cases of ankylosing spondylitis,dermatomyositis/polymyositis, polymyalgia rheumatica, psoriatic arthritis, relapsing polychondritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Sjogren’s syndrome, Systemic lupus erythematosus, and vasculitis. Flo-Pred is indicated for the treatment of rheumatologic conditions such as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis. Flo-Pred is indicated for the treatment of specific infectious diseases such as trichinosis with neurologic or myocardial involvement and tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Fludarabine phosphate tablet formulation Oral fludarabine has been approved as a second-line treatment for chronic lymphocytic leukaemia. The product provides an alternative means to administer fludarabine that avoids the need for patients to have an intravenous infusion. Antisoma plans to make the drug available to U.S. patients through a commercialization deal. Talks are ongoing with a number of companies that have established oncology marketing operations in the United States. Antisoma expects to conclude a deal early in 2009. Oral and intravenous formulations of fludarabine are in use in Europe, Canada, and elsewhere, but until now only the intravenous formulation has been available in the United States. In France and the United Kingdom, the oral formulation has been widely adopted, representing about 60% to 70% of fludarabine prescriptions. Fusilev Levoleucovorin for injection is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin. The product is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. Levoleucovorin is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. Granisol Granisol is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin; and for the prevention of nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. Intelence Intelence is the first new non-nucleoside reverse transcriptase inhibitor to be introduced in nearly 10 years. The product is also the first non-nucleoside reverse transcriptase inhibitor to show antiviral activity in patients with non-nucleoside reverse transcriptase inhibitor-resistant virus. Intelence is indicated, in combination with other antiretroviral agents, for HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretroviral agents. Non-nucleoside reverse transcriptase inhibitors block reverse transcriptase, a key enzyme the HIV virus uses to replicate. Non-nucleoside reverse transcriptase inhibitor drug resistance occurs when HIV develops mutations that partially or completely stop the non-nucleoside reverse transcriptase inhibitor from binding to the reverse transcriptase enzyme, causing the drug to lose effectiveness. Keppra XR (keppraxr.com) Keppra XR is indicated for use as an add-on to other antiepileptic treatments for people with partial onset seizures who are 16 years old and older. The goal of therapy with antiepileptic drugs is freedom from seizures and minimal side effects. The immediate release tablet form of Keppra was first approved by FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since then, Keppra has become a leading antiepileptic drug in the United States. Kinrix (kinrix.com) Kinrix is the first combination vaccine to offer protection against diphtheria, tetanus, pertussis, and polio diseases in one shot. By reducing the number of shots given in one visit, combination vaccines like Kinrix may make it easier for children to meet school vaccination requirements and CDC recommendations. Kinrix is approved for children 4 years old to 6 years old whose previous diphtheria and tetanus toxoids and acellular pertussis vaccinations have been with Pediarix and/or Infanrix. Latisse (latisse.com) Latisse 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. Latisse is the first and only science-based treatment approved by FDA to enhance eyelash prominence as measured by increases in length, thickness, and darkness of eyelashes. Latisse is applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. Latisse users can expect to experience longer, fuller, and darker eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain effect, continued treatment with Latisse is required. If use of Latisse is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months. Latisse was first approved in 2001 as a medical product to lower intraocular pressure in people with open-angle glaucoma or ocular hypertension. Patients treated with bimatoprost for this specific eye condition experienced eyelash growth as a side effect. Lexiscan Lexiscan is an A2A adenosine receptor agonist for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging – a test that detects and characterizes coronary artery disease – in patients unable to undergo adequate exercise stress. Lexiscan is the first A2A adenosine receptor agonist shown to be safe and effective as a pharmacologic stress agent in myocardial perfusion imaging studies. Lexiscan is delivered as a rapid bolus (about 10 seconds) with no dose adjustment required for body weight. The A2A adenosine receptor is the adenosine receptor subtype responsible for coronary vasodilation. Under a license and collaboration agreement providing Astellas with exclusive North American rights to Lexiscan, CV Therapeutics Inc. (cvt.com) manages the development program and Astellas is responsible for all commercial activities for Lexiscan in North America. LoSeasonique LoSeasonique is the first lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy. Under the LoSeasonique extended-cycle regimen, women take combination tablets containing 0.10 milligrams levonorgestrel/0.02 milligrams of ethinyl estradiol daily for 84 consecutive days, followed 0.01 milligrams ethinyl estradiol tablets for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo. Lusedra Lusedra is an intravenous sedative-hypnotic agent for monitored anesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures. Lusedra can be used only by persons trained in the administration of general anesthesia, and all patients should be continuously monitored by persons not involved in the conduct of the procedure. FDA has recommended that Lusedra be classified as a controlled substance. Lusedra is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. Luvox CR (luvoxcr.com) Once-a-day Luvox CR extended-release capsules are indicated for the treatment of social anxiety disorder and obsessive compulsive disorder in adults. Luvox CR is a selective serotonin reuptake inhibitor that incorporates Elan’s proprietary spheroidal oral drug absorption system technology designed to minimize peak-to-trough plasma level fluctuations over a 24-hour period. Mesalamine Delayed-Release Tablet, 800 milligrams Mesalamine Delayed-Release Tablets, 800 milligrams, are approved for the treatment of moderately active ulcerative colitis. The mechanism of action of mesalamine is unknown but appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways and through the lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon. Morphine Sulfate Tablets and Oral Solution CII Roxane Laboratories’ Morphine Sulfate CII is available in 15-milligram and 30-milligram tablet strengths and 10-milligram/5milliliter, 20milligram/5milliliter oral solution strengths. Morphine Sulfate is indicated for the relief of moderate to severe acute and chronic pain where an opioid analgesic is appropriate. Moxatag Moxatag is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years old or older. Mozobil Mozobil is intended to be used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. The product has also been granted orphan drug designation. Mozobil is designed to mobilize hematopoietic stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for patients with certain types of cancers to proceed to transplant. Currently, before a transplant can take place, patients may receive a prescribed dose of chemotherapy and/or other drugs called growth factors to help mobilize their hematopoietic stem cells into the bloodstream. Once the cells are released into the bloodstream, they are collected in preparation for a transplant. In order for the transplant to take place, a minimum number of about 2 million stem cells per kilogram of body weight must be collected. For many patients, this process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible. Navstel Solution Navstel Solution is indicated for use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye. Nexium Delayed-Release Oral Suspension, 10 milligrams Nexium Delayed-Release Oral Suspension, 10 milligrams, is indicated for the short-term treatment of gastroesophageal reflux disease in pediatric patients of 1-11 years old. Nexterone Nexterone is indicated for initiation of treatment and prevention of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Nicardipine hydrochloride Injection Nicardipine hydrochloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible. Novolog Mix 50/50 Novolog Mix 50/50 is indicated as an adjunct to diet and exercise to improve glycemic control in patients with diabetes mellitus. Nplate (nplate.com) Nplate is the first and only platelet producer for the treatment of thrombocytopenia in splenectomized and non-splenectomized adults with chronic immune thrombocytopenic purpura. The first FDA-approved peptibody protein, Nplate works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease. OraVerse OraVerse is indicated for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. Patanase Patanase nasal spray is an extension to Alcon’s market-leading ocular allergy product line. The product is approved for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years old and older. PegIntron/Rebetrol Combo Pack PegIntron/Rebetrol Combo Pack is indicated for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years old. Pentacel Pentacel vaccine is the first and only four-dose diphtheria, tetanus, and acellular pertussis-based combination vaccine for use in infants and young children in the United States that includes both poliovirus and Hemophilus influenzae type b antigens. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Hemophilus influenzae type b. The vaccine is approved for use in infants and children 6 weeks old through 4 years old. Pentacel vaccine is also the first five-component pediatric combination vaccine in the United States to contain Sanofi Pasteur’s five acellular pertussis antigens, which are also used in its DTaP vaccine for children and its tetanus, diphtheria, and acellular pertussis vaccine for adults and adolescents. PrandiMet PrandiMet is the first and only fixed-dose combination of the fast-acting secretagogue replaglinide and insulin sensitizer, metformin, for the treatment of type 2 diabetes. PrandiMet has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin. Nov. 19, 2007, Sciele signed an exclusive agreement with Novo Nordisk Inc. (novonordisk-us.com) to market Prandin. The combination of metformin and repaglinide has been shown to safely and effectively reduce hemoglobin A1c levels. PrandiMet offers the convenience of two medications in one pill: Prandin, a fast-acting insulin secretagogue, and metformin, an insulin sensitizer. Prandin stimulates the release of insulin from the pancreas after a meal, thereby reducing PPG. Metformin decreases the amount sugar produced by the liver, reducing FPG, and helps the body respond better to the insulin it makes naturally. Prilosec Delayed Release Oral Suspension Prilosec Delayed Release Oral Suspension is indicated for the healing of erosive esophagitis in pediatric patients 1 to 2 years old. The product is also approved for the treatment of gastroesophageal reflux disease in pediatric patients 1 to 2 years old. Pristiq Pristiq is a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor. The product is indicated, to treat adult patients with major depressive disorder. Pristiq delivers the major active metabolite of Effexor XR in its active state without going through the CYP2D6 metabolic pathway. This could be beneficial when Pristiq is coadministered with other commonly prescribed medications metabolized through that pathway. Promacta Promacta is the first oral thrombopoietin receptor agonist approved for adult patients with chronic immune thrombocytopenic purpura. Promacta received accelerated approval from FDA for for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Promacta is an oral, non-peptide thrombopoietin receptor agonist that has been shown in pre-clinical research and clinical trials to stimulate the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. Promacta was discovered as a result of a research collaboration between GlaxoSmithKline and Ligand Pharmaceuticals (ligand.com). The product was developed by GlaxoSmithKline. Rapaflo Rapaflo is a new alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia. Benign prostatic hyperplasia is the No. 1 reason patients visit urologists and is characterized by urination problems, including decreased urine flow, more frequent urination, and nocturia. The U.S. benign prostatic hyperplasia market is growing and exceeds $2 billion annually, of which $1.7 billion is attributed to alpha blockers. Rapaflo is a selective alpha-1 adrenergic receptor antagonist that binds with high affinity to the alpha receptors concentrated in the prostate, causing the smooth muscles in these tissues to relax and resulting in improved urine flow and a reduction in benign prostatic hyperplasia symptoms. The binding affinity for the alpha (1B) receptors that cause smooth muscle relaxation and blood pressure effects is significantly lower, thereby maximizing target organ activity for treating benign prostatic hyperplasia and minimizing the potential for side effects and interactions with other therapies. Recothrom Recothrom is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. The product is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, Recothrom gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled up to meet market demand. Recothrom is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Recothrom may be used in conjunction with an absorbable gelatin sponge, USP. Relistor Relistor is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. In clinical studies, Relistor significantly decreased the constipating effects of opioids without interfering with pain relief. Relistor, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. Opioids provide pain relief by specifically interacting with mu-opioid receptors within the central nervous system. Opioids, however, also interact with mu-opioid receptors found outside the central nervous system, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. Relistor selectively displaces opioids from the mu-opioid receptors outside the central nervous system, including those located in the gastrointestinal tract, thereby decreasing their constipating effects. In December 2005, Wyeth and Progenics Pharmaceuticals Inc. (progenics.com) entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone for the treatment of opioid-induced side effects. Requip XL Requip XL is the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson’s disease. The product is approved in the United States for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma Plc.’s (skyepharma.com) patented Geomatrix technology. This tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Rotarix Rotarix is approved for the prevention of rotavirus gastroenteritis in infants. Rotarix will offer protection against the most commonly circulating rotavirus types in the United States and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention currently recommends that children complete the rotavirus immunization series by six months of age. Rotarix is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of Rotarix have been distributed worldwide. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Ryzolt Labopharm’s first product in the United States, Ryzolt is a once-daily formulation of the analgesic tramadol. The product is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Ryzolt is a centrally acting analgesic composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics. Labopharm’s marketing partner for the product in the United States, Purdue Pharma, anticipates launching Ryzolt tablets in 100-milligram, 200-milligram, and 300-milligram dosage strengths in the second quarter of 2009. Sancuso Sancuso is the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen. Sancuso is a transdermal system, or skin patch, that delivers granisetron, its active component and an established inhibitor of nausea and vomiting, through a thin layer of adhesive that attaches the patch to the skin. The medicine is then released slowly and continuously into the bloodstream for up to five consecutive days. Simcor Simcor is a fixed-dose combination lipid therapy developed by Abbott. Solvay Pharmaceuticals was granted joint-promotion rights in the United States for Simcor as a result of an agreement with Abbott announced Oct. 22, 2007. Simcor combines Niaspan and simvastatin, to target multiple lipid parameters – LDL “bad” cholesterol and HDL “good” cholesterol – in a single pill. Simcor is used when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate, and when diet and other non-drug measures alone have not been successful. Stavzor Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches. Stavzor soft gel capsules are small and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability. Banner Pharmacaps Inc. (banpharm.com), Noven’s development partner for this product, developed Stavzor using its EnteriCare enteric soft gelatin capsule delivery system, and submitted the Stavzor new drug application to FDA. Synthetic Conjugated Estrogens-A 0.625 mg/g Vaginal Cream. SCE-A Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause. The product is administered intravaginally at a dose of 1 gram daily for one week, followed by 1 gram intravaginally twice a week. Taclonex Scalp Taclonex Scalp is a topical suspension containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of moderate to severe psoriasis vulgaris of the scalp in adults. Taclonex Scalp is called Xamiol outside the United States. Warner Chilcott is LEO Pharma Inc.’s (leo-pharma.com) exclusive licensee of Taclonex in the United States. Tapentadol immediate-release tablets Tapentadol is a new centrally acting oral analgesic indicated for the relief of moderate to severe acute pain in adults 18 years old or older. The drug has two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition. Tapentadol tablets have been approved in 50-milligram, 75-milligram, and 100-milligram doses. Following FDA approval, and as per Federal regulation for all controlled substances, tapentadol will be reviewed by the U.S. Drug Enforcement Agency for scheduling and cannot be sold until it receives a scheduling classification. A trade name for tapentadol has not yet been determined. Tekturna HCT Tekturna HCT is a single-tablet combination of two high blood pressure medicines – Tekturna, the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide. The two medicines in this single-tablet combination work together to lower blood pressure, with clinical data showing that the combination of Tekturna and HCT offers greater blood pressure reductions than either component alone. This is the first regulatory approval of a single-tablet combination therapy involving Tekturna, known as Rasilez outside the United States, which has been shown to consistently lower blood pressure for 24 hours and beyond. HCT, sometimes called a “water pill,” is one of the most commonly used high blood pressure medicines. Tekturna HCT is approved for patients not controlled by either medicine alone. Toviaz (toviaz.com) Toviaz is indicated for the treatment of overactive bladder symptoms. New once-daily Toviaz can significantly reduce the number of urge urinary incontinence episodes and the frequency of urination over 24 hours, symptoms of overactive bladder that can significantly affect patients’ lives. Overactive bladder is a bothersome medical condition that affects an estimated one in six Americans, yet still remains highly undertreated. Structurally related to the most prescribed overactive bladder medication, Pfizer’s Detrol LA, Toviaz can help regulate the involuntary contractions of the bladder associated with overactive bladder. These contractions cause frequent, sudden urges to urinate. The two efficacious and well-tolerated doses of Toviaz, 4 milligrams and 8 milligrams, allow dosing flexibility to optimize treatment based on the individual patient response and tolerability. Treanda Treanda is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The data supporting the FDA approval show that Treanda is effective, has a tolerable side effect profile in patients with indolent non-Hodgkin’s lymphoma, and that treatment results in a high durable response rate. In March 2008, Treanda received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the United States. Treanda is a novel treatment with a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of Treanda remains unknown, Treanda may act in two distinct ways to kill cancer cells. Preclinical studies suggest that Treanda may lead to cell death by a process known as apoptosis as well as by an alternate cell death pathway that disrupts normal cell division known as mitotic catastrophe, a non-apoptotic pathway. Treanda I.V. Treanda I.V. is indicated for intravenous infusion, for the treatment of patients with chronic lymphocytic leukemia. Treximet Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GlaxoSmithKline, and an anti-inflammatory pain reliever in a single tablet. The product is indicated for the acute treatment of migraine attacks with or without aura in adults. Treximet contains 85 milligrams of sumatriptan, formulated with RT Technology, and 500 milligrams of naproxen. Sumatriptan is the active ingredient in Imitrex tablets. Trilipix Trilipix is first and only fibrate indicated for use in combination with a statin for cholesterol management. FDA approved the drug for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to improve lipid levels. TriLipix has not been shown to prevent heart disease or heart attack. Trivaris Trivaris is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via intravitreal injection, the ophthalmic indications for Trivaris include sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. These are inflammatory conditions that can result in vision loss. Vasovist Vasovist is the first contrast agent approved for marketing in the United States for use with magnetic resonance angiography, a non-invasive modality for imaging blood vessels. The drug is approved to evaluate aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease. Aortoiliac occlusive disease occurs when iliac arteries become narrowed or blocked and may prevent the sufficient transport of oxygen and/or blood throughout the body. Vasovist is a first-in-class contrast agent with several unique characteristics. The product offers good resolution angiography, a high signal per dose, a long imaging window timeframe ,and single-dose imaging of multiple vessel beds. In addition, the albumin-binding properties of Vasovist make the product ideal for vascular imaging as opposed to other gadolinium agents that are rapidly cleared from the blood stream and have a narrow imaging window. Vimpat Injection Vimpat Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years old or older when oral administration is temporarily not feasible. Vimpat Tablet The new antiepileptic drug Vimpat is for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years old and older. Vimpat works unlike any other antiepileptic drug available. In preclinical studies, Vimpat’s mechanism of action has been shown to involve the modulation of sodium channel activity in the nervous system. Sodium channels play a crucial role in regulating the activity of the nervous system to help nerve cells communicate. Sometimes sodium channels become abnormally overactive and nerve cells become too excited, which may produce a seizure. Vimpat’s mechanism of action is thought to reduce this sodium channel over-activity by prolonging the longer lasting resting state of the channel, a different action compared with current sodium channel blocking drugs. This action then regulates the activity of over-excited nerve cells, which may contribute to the control of seizures. In preclinical studies, Vimpat has also been shown to bind to the collapsin response mediator protein-2 an important target that affects the way that nerves differentiate and grow. Venlafaxine Hydrochloride extended-release 37.5-milligram, 75-milligram, 150-milligram, and 225-milligram tablets Venlafaxine is approved for major depressive disorder and social anxiety disorder. The Osmotica product provides a controlled release tablet form of venlafaxine HCl, including a previously unavailable 225-milligram dosage strength. Equal doses of venlafaxine HCl extended-release Tablets are bioequivalent to Effexor XR capsules, a leading product marketed by Wyeth (wyeth.com), when administered under fed conditions. Xenazine Xenazine is the first and only FDA-approved treatment for any symptom of Huntington’s disease. The drug is indicated for the treatment of chorea associated with Huntington’s disease. Sept. 17, 2008, Ovation Pharmaceuticals acquired from Prestwick Pharmaceuticals (prestwickpharma.com) the exclusive license in the United States to commercialize Xenazine. A selective and reversible centrally-acting dopamine depleting drug, Xenazine works by inhibiting a molecule known as vesicular monoamine transporter 2. Xenazine has been designated as an orphan drug by FDA and will have seven years market exclusivity in the United States. Xyntha Xyntha is indicated for the control and prevention of bleeding episodes in patients with hemophilia A and for surgical prophylaxis in patients with hemophilia A. A recombinant factor VIII product, Xyntha is manufactured using a completely albumin-free process and state-of-the-art nanofiltration purification technology. In addition, Xyntha is the only recombinant factor VIII product to utilize an entirely synthetic purification process in its manufacture. Xyzal (xyzal.com) Xyzal oral solution is indicated for the relief of symptoms associated with allergic rhinitis, seasonal and perennial, and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years old and older. In September 2006, UCB and Sanofi-Aventis entered into an agreement to launch and co-market Xyzal in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms. Zolpimist Zolpimist contains zolpidem, the same active ingredient as Ambien, the world’s leading sedative hypnotic for the treatment of insomnia. Indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation, Zolpimist provides rapid absorption from the oral mucosa. The drug is NovaDel’s second product approved by FDA that uses NovaDel’s proprietary NovaMist oral spray technology. | ||||||
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