Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride, indicating regulatory clearance for the generic product from PAI Ho…
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FDA approval · 2019-10-08FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Lannett Company, Inc.
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FDA approval · 2019-10-08FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product developed by …
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FDA approval · 2019-10-07FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadose (methadone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2019-10-07FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) from Indivior Inc., indicating a supplemental approval for the…
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FDA approval · 2019-10-07FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for methadone hydrochloride by Mylan Institutional LLC, resulting in updates to the product labeling…
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FDA approval · 2019-10-07FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) from Orexo US, Inc.
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FDA approval · 2019-10-07FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.’s supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydr…
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FDA approval · 2019-10-07FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine extended-release injection) from Indivior Inc., resulting in update…
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FDA approval · 2019-10-07FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine submitted by Hikma Pharmaceuticals USA Inc., authorizing changes to an approved ge…
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FDA approval · 2019-10-02FDA Approved: METHADONE HYDROCHLORIDE — Original Application (SpecGx LLC)
FDA approved an original application for methadone hydrochloride from SpecGx LLC, resulting in a generic version of this opioid product.
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FDA approval · 2019-09-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Buprenorphine and naloxone submitted by Actavis Pharma, Inc. The approval relates to a supplemen…
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FDA approval · 2019-09-23FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application to approve a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from S…
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FDA approval · 2019-09-23FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc., associated with an existing approved product.
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FDA approval · 2019-08-22FDA Approved: METHADONE HYDROCHLORIDE — Original Application (SpecGx LLC)
FDA approved a generic methadone hydrochloride product (SpecGx LLC) under an Original Application.
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FDA approval · 2019-06-07FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, Inc.
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EMA approval · 2019-04-26New long-lasting implant to treat opioid dependence
The EMA reports a new long-acting implant for the treatment of opioid dependence, expanding available options for managing opioid use disord…
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FDA approval · 2019-01-24FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Original Application (Alvogen Inc.)
FDA approved a generic buprenorphine and naloxone sublingual film (Original Application) for the treatment of opioid dependence, with Alvoge…
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FDA approval · 2019-01-03FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc)
FDA approved Camber Pharmaceuticals' Methadone Hydrochloride Original Application (ANDA 211228).
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FDA approval · 2018-12-28FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., authorizing changes to the product's labeling under a…
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FDA approval · 2018-11-20FDA Approved: BUPRENORPHINE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s original application for generic buprenorphine, enabling its marketing in the United States fo…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA granted a supplemental approval to Amneal Pharmaceuticals for Buprenorphine HCl and Naloxone HCl, expanding the product's approved formu…
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FDA approval · 2018-10-31FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV, the buprenorphine/naloxone sublingual product from Orexo US, Inc.
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental NDA for buprenorphine hydrochloride and naloxone hydrochloride dihydrate manufactured by Hikma Pharmaceutica…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for Sun Pharmaceutical's buprenorphine/naloxone product, updating its regulatory status for treating…