Sublingual film – 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

FDA Rejects Sunovion’s Parkinson’s Disease Drug

Approvals, Complete Response Letter, FDA, FDA/Regulatory, Licensing, New Drug Application (NDA), OFF Episodes, Parkinson's Disease, Sublingual film

The U.S. Food and Drug Administration rejected Sunovion Pharmaceuticals’ experimental treatment apomorphine sublingual film (APL-130277) for OFF episodes of Parkinson’s disease.

January 31, 2019/by BioSpace