Alcohol Dependence

• EMA approval · 2025-10-07
  EMA Authorised: Selincro (nalmefene hydrochloride dihydrate) — H. Lundbeck A/S

  The European Medicines Agency authorised Selincro (nalmefene hydrochloride dihydrate) by H. Lundbeck A/S for alcohol-related disorders, incl…

• FDA approval · 2025-09-18
  FDA Approved: ACAMPROSATE CALCIUM — Original Application (Bionpharma Inc.,)

  FDA approved the original application for a generic acamprosate calcium product from Bionpharma Inc., authorizing a generic version to help …

• FDA approval · 2022-09-30
  FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.

• FDA approval · 2019-09-06
  FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., resulting in an updated/expanded approval.

• FDA approval · 2016-01-19
  FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for VIVITROL (naltrexone extended-release) from Alkermes, Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2014-03-11
  FDA Approved: ACAMPROSATE CALCIUM — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for acamprosate calcium enteric-coated (generic), manufactured by Mylan Pharmaceuticals Inc. for the t…

• FDA approval · 2014-01-07
  FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)

  The FDA approved a supplemental application for VIVITROL (naltrexone long-acting injectable) submitted by Alkermes, Inc. The action updates/…

• FDA approval · 2013-08-08
  FDA Approved: DISULFIRAM — Original Application (Alvogen Inc.)

  FDA approved Disulfiram from Alvogen Inc. as an original generic application for the treatment of alcohol dependence/alcohol use disorder.

• EMA approval · 2012-12-14
  European Medicines Agency recommends approval of medicine for reduction of alcohol consumption

  The EMA recommends approval of a medicine aimed at reducing alcohol consumption, indicating regulatory support for a new treatment option to…

• FDA approval · 2011-08-17
  FDA Approved: NALTREXONE HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved an original application for Naltrexone hydrochloride from Accord Healthcare, Inc., adding a generic option for the treatment of…

• FDA approval · 2010-10-12
  FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc., indicating an updated or expanded regulatory indication…