Sublingual Archives - PharmaLive

BioXcel Therapeutics Announces FDA Approval of IGALMI Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

Agitation, Approvals, Artificial Intelligence, Bipolar II Disorder, FDA, Product Launches, Schizophrenia, Sublingual film

The U.S. Food and Drug Administration approved BioXcel Therapeutics Inc.’s IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

April 6, 2022/by GlobeNewswire

FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug

Approvals, Cells, Complete Response Letter, FDA, FDA/Regulatory, Neurodegenerative Disorders, OFF Episodes, Parkinson's Disease, Sublingual film, The Lancet

The U.S. Food and Drug Administration approved Marlborough, Massachusetts-based Sunovion Pharmaceuticals’ Kynmobi (apomorphine HCl) sublingual film for Parkinson’s disease.

May 22, 2020/by BioSpace

FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion

Blockbusters, BRCA mutation, Clinical Trial Endpoints, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), New Drug Applications, Non-Small Cell Lung Cancer (NSCLC), OFF Episodes, Parkinson's Disease, PDUFA, Sublingual film, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics

Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.

May 11, 2020/by Andrew Humphreys

FDA Clears Sublingual Form of Aquestive’s ALS Drug

Amyotrophic Lateral Sclerosis (ALS), Approvals, FDA, FDA/Regulatory, Neurodegenerative Diseases, Prescription Drug User-Fee Act (PDUFA), Sublingual film

Shares of Aquestive Therapeutics were up more than 18 percent following approval from the U.S. Food and Drug Administration for Exservan, a treatment for amyotrophic lateral sclerosis (ALS).

November 25, 2019/by BioSpace

Camurus Announces Publication of Phase 3 Study Results Showing Long-term Safety, Efficacy and High Rates of Patient Satisfaction With Buvidal

Addiction, Clinical Trials, Opioid Dependence, R&D, Sublingual

Camurus announced that the leading drug dependence journal Addiction published full results from a 48-week, open-label, global Phase 3 study of weekly and monthly Buvidal (prolonged-release buprenorphine), the first long-acting injection medicine to be approved for the treatment of opioid dependence in the EU and Australia.

June 4, 2019/by PR Newswire

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

Crisis, Department of Health and Human Services (HHS), FDA/Regulatory, Generics, Opioid Dependence, Opioids, Opioids, Sublingual

The U.S. Food and Drug Administration approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence.

June 14, 2018/by PR Newswire