Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
The FDA approved SpecGx LLC's supplemental application for a buprenorphine hydrochloride and naloxone hydrochloride dihydrate product, a gen…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approves a supplemental application for buprenorphine and naloxone from Mylan Pharmaceuticals, signaling an update to the product's appr…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for buprenorphine and naloxone from Dr. Reddy's Laboratories. The approval supports continued use of…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc., granting approval for changes to an already-a…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride (ANDA090622) filed by PAI Holdings, LLC dba Pharmaceutical Associate…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for Actavis Pharma's generic buprenorphine/naloxone product for the treatment of opioid dependen…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a buprenorphine and naloxone product from PAI Holdings, LLC dba Pharmaceutical Associates, Inc. …
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine submitted by Actavis Pharma, Inc. under ANDA090819. The action confirms approval o…
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FDA approval · 2018-10-26FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) submitted by INDIVIOR INC.
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FDA approval · 2018-09-21FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., granting approval for this generic …
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FDA approval · 2018-09-21FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved VistaPharm's supplemental application for methadone hydrochloride, authorizing a supplemental generic product for manufacturing…
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FDA approval · 2018-09-18FDA Approved: METHADOSE DISPERSIBLE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for METHADOSE DISPERSIBLE (methadone hydrochloride) from SpecGx LLC under ANDA 074184.
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., enabling the generic formulatio…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. to support a generic methadone hydro…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for Methadone Hydrochloride from VistaPharm, LLC, granting approval of a generic Methadone Hydro…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC, approving the generic product for distribution…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Elite Laboratories, Inc.)
FDA approved a supplemental application for Elite Laboratories' methadone hydrochloride (ANDA 210484), authorizing its continued marketing a…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc.
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FDA approval · 2018-08-02FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Elite Laboratories, Inc.)
FDA approved an Original Application for a generic methadone hydrochloride product from Elite Laboratories, Inc. (ANDA210484).
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FDA approval · 2018-06-14FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved the original application for a generic buprenorphine and naloxone product manufactured by Dr. Reddy's Laboratories Inc. This ma…
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FDA approval · 2018-06-14FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' buprenorphine and naloxone generic combination for the treatment of opioid dependence (ANDA 205299).
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FDA approval · 2018-06-11FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) submitted by INDIVIOR INC., approving changes to the existing …
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FDA approval · 2018-05-16FDA Approved: LUCEMYRA — Original Application (USWM, LLC)
FDA approved LUCEMYRA (lofexidine hydrochloride) as an original NDA for reducing opioid withdrawal symptoms during detoxification.
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FDA approval · 2018-03-05FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine) from Indivior Inc., expanding its regulatory labeling.
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FDA approval · 2018-02-01FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine and naloxone) from Orexo US, Inc. This action updates the product's label…