Opioid Dependence

• FDA approval · 2016-12-16
  FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

  FDA approved a supplemental application for a generic buprenorphine and naloxone product (PAI Holdings/PAI Pharma).

• FDA approval · 2016-07-07
  FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate from Hikma Pharmaceuticals USA …

• FDA approval · 2016-04-20
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. The approval covers labeling and…

• 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.

• 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/…

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• 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…