Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-06-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC.
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FDA approval · 2024-06-12FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Mylan Pharmaceuticals Inc. The approval updates the product'…
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FDA approval · 2024-06-12FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Mylan Pharmaceuticals Inc., supporting continued use for tre…
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FDA approval · 2024-05-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA)
The FDA approved a supplemental application for methadone hydrochloride by Hikma Pharmaceuticals USA, bringing a generic version of the drug…
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FDA approval · 2024-04-19FDA Approved: REZENOPY — Original Application (Scienture LLC)
FDA approved REZENOPY (naloxone hydrochloride) from Scienture LLC under an Original New Drug Application. It is approved as an emergency rev…
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FDA approval · 2024-04-19FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
FDA approves a supplemental application for SUBLOCADE (buprenorphine) by Indivior Inc., potentially updating the product’s labeling or indic…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application from Lannett Company for a buprenorphine/naloxone product, expanding access to a generic treatme…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved the supplemental application for buprenorphine HCl and naloxone HCl from Amneal as a generic product for the treatment of opioi…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product to treat opio…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc. under ANDA090819, granting regulatory clearance for this…
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FDA approval · 2024-03-20FDA 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 (buprenorphine hydrochloride and naloxone hydrochlo…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate from SpecGx LLC.
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for Buprenorphine and Naloxone from Dr. Reddy's Laboratories, enabling market authorization for this…
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FDA approval · 2024-03-20FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine hydrochloride and naloxone hydrochloride) from Indivior Inc., related to…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride from PAI Holdings/PAI Pharma. This approval updates the product’s la…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc., under an ANDA. This generic product is use…
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FDA approval · 2024-03-20FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV, a buprenorphine/naloxone product, manufactured by Orexo US, Inc.
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Sun Pharmaceutical's buprenorphine/naloxone product, granting regulatory authorization for this …
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for BUPRENORPHINE AND NALOXONE from Mylan Pharmaceuticals Inc., confirming regulatory action on the …
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for a generic Buprenorphine and Naloxone product from Dr. Reddy's Laboratories Inc.
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (INGENUS PHARMACEUTICALS, LLC)
The FDA approved a supplemental application for buprenorphine and naloxone from Ingenus Pharmaceuticals, LLC, confirming approval of the gen…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for the generic buprenorphine and naloxone product from Rhodes Pharmaceuticals L.P.
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for Buprenorphine and naloxone sublingual film from Alvogen Inc.
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
FDA approved a supplemental application for Accord Healthcare's generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate pro…
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FDA approval · 2024-03-20FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Mylan Pharmaceuticals Inc., confirming the changes approved …