Amryt Pharma said on February 28 the U.S. Food and Drug Administration declined to approve the company’s drug for the treatment of a group of rare skin diseases called epidermolysis bullosa.
FDA Action Alert: Jazz, ANI and Ultragenyx
Approvals, Cataplexy, Excessive Daytime Sleepiness, Fatty Acids, FDA, FDA/Regulatory, Gels, Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Multiple Sclerosis, Narcolepsy, New Drug Applications, PDUFA, Refusal to File letter, Rheumatoid Arthritis, Supplemental New Drug Application (sNDA), Systemic Lupus Erythematosus (SLE), Ulcerative ColitisU.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
The U.S. Food and Drug Administration approved Evofem Biosciences Inc.’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Mallinckrodt receives SEC subpoena over Acthar gel lawsuit
Addictions, Business, Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), Gels, Generics, Infantile Spasms, Lawsuits, Manufacturing, Multiple Sclerosis, Opioid Litigation, Opioids, Shares, U.S. Securities and Exchange Commission (SEC)Mallinckrodt Plc received a subpoena from the U.S. Securities and Exchange Commission for documents related to the drugmaker’s lawsuit against the U.S. Department of Health and Human Services (HHS).
The Australian subsidiaries of British drugmaker GlaxoSmithKline and Swiss drugmaker Novartis misled customers and broke the law by promoting identical liniments as though they could treat specific ills, an Australian court found.
The U.S. FDA approved Bausch + Lomb’s Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for treating postoperative inflammation and pain following ocular surgery.