Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-02-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approves SpecGx LLC's supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate, enabling a generic …
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FDA approval · 2021-02-08FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC. This action updates the regulatory status of th…
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FDA approval · 2021-02-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone by Sun Pharmaceutical Industries, Inc. under an ANDA, indicating regu…
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FDA approval · 2021-02-02FDA Approved: BUPRENORPHINE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for buprenorphine submitted by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2021-01-14FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Amneal's generic buprenorphine HCl and naloxone HCl product.
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FDA approval · 2021-01-13FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for Buprenorphine and naloxone from Actavis Pharma, Inc., authorizing changes to the approved pr…
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FDA approval · 2020-11-02FDA Approved: METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED — Original Application (Lannett Company, Inc.)
FDA approved Lannett's methadone hydrochloride dye-free, sugar-free, unflavored product through an Original Application (ANDA), adding a new…
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FDA approval · 2020-07-17FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Original Application (Accord Healthcare, Inc)
FDA approves Accord Healthcare's generic combination product of buprenorphine hydrochloride and naloxone hydrochloride dihydrate for opioid …
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FDA approval · 2020-06-23FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for buprenorphine hydrochloride submitted by Par Health USA, LLC.
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FDA approval · 2020-06-15FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved Indivior's supplemental application for SUBLOCADE (buprenorphine), resulting in regulatory action on the product's labeling…
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FDA approval · 2020-06-15FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approves Hikma Pharmaceuticals USA Inc.'s supplemental application for buprenorphine hydrochloride, enabling a generic product entry…
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FDA approval · 2020-05-08FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, Inc., updating the product labeling.
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FDA approval · 2020-05-05FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride manufactured by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2020-04-17FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original application for a generic buprenorphine/naloxone product for the treatment of opioid use disorder.
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FDA approval · 2020-03-30FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Rhodes Pharmaceuticals L.P.)
FDA approved the original application for a buprenorphine and naloxone combination product from Rhodes Pharmaceuticals L.P. for the treatmen…
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FDA approval · 2020-03-16FDA Approved: METHADONE HYDROCHLORIDE — Original Application (VistaPharm, LLC)
FDA approves VistaPharm's methadone hydrochloride as a generic drug under an original ANDA; the product is intended for analgesic use and fo…
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FDA approval · 2020-03-02FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) submitted by Indivior Inc. The update covers the approved …
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FDA approval · 2020-02-04FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine) from Indivior Inc., resulting in updated labeling.
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FDA approval · 2019-10-31FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) submitted by Indivior Inc.
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FDA approval · 2019-10-11FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride by VistaPharm, LLC.
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FDA approval · 2019-10-09FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for a generic methadone hydrochloride product from Hikma Pharmaceuticals USA Inc., granting marketin…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc., indicating regulatory approval to modi…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for a generic buprenorphine and naloxone product from PAI Holdings/PAI Pharma, authorizing the A…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for buprenorphine from Sun Pharmaceutical Industries, granting approval of the generic product.
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Sun Pharmaceutical Industries' buprenorphine and naloxone product. This action grants regulatory…