Opioid Dependence
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-04-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA has approved a supplemental application for buprenorphine and naloxone from Dr. Reddy's Laboratories, updating an already approved produ…
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FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic buprenorphine/naloxone product from Lannett Company for the treatment of opioid depend…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
FDA approved Accord Healthcare's supplemental ANDA for buprenorphine hydrochloride and naloxone hydrochloride dihydrate, a generic product i…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride manufactured by VistaPharm, LLC.
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FDA approval · 2024-06-12FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)
FDA approved Hospira's supplemental application for Buprenorphine Hydrochloride, updating the approved product's labeling and/or specificati…
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FDA approval · 2023-12-15FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) from Indivior Inc., authorizin…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for a buprenorphine and naloxone product. The approval pertains …
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FDA approval · 2023-09-12FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine) from Indivior Inc., updating the product labeling as part of a sup…
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FDA approval · 2023-06-07FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Actavis Pharma’s generic buprenorphine/naloxone product for the treatment of opioid dependence. …
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for the generic buprenorphine and naloxone sublingual film from Alvogen Inc., authorizing market aut…
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FDA approval · 2022-09-30FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.
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FDA approval · 2022-06-17FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) by Orexo US, Inc., updating…
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FDA approval · 2022-06-14FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for a buprenorphine HCl and naloxone HCl product, providing a generic opt…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved Actavis Pharma's supplemental application for a buprenorphine and naloxone product (generic Suboxone) under ANDA, enabling …
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved Actavis Pharma, Inc.'s supplemental application for buprenorphine and naloxone, authorizing an updated approval for this pr…
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FDA approval · 2021-03-04FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA issued approval of a supplemental application for Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) by Indivior Inc.…
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FDA approval · 2021-03-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc. The approval covers changes to labeling and…
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FDA approval · 2021-03-04FDA 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 from SpecGx L…
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FDA approval · 2019-10-09FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for METHADONE HYDROCHLORIDE by Hikma Pharmaceuticals USA Inc., granting approval for a supplemental …
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FDA approval · 2019-09-06FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., resulting in an updated/expanded approval.
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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 · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett Company's generic buprenorphine and naloxone product, enabling marketing of a generic fo…
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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 a generic buprenorphine/naloxone product (Dr. Reddy's Laboratories) under ANDA 205299. The appro…
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FDA approval · 2018-06-14FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original Abbreviated New Drug Application for buprenorphine and naloxone tablets, a generic treatment for opioid depend…
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals LLC's supplemental application for a buprenorphine HCl and naloxone HCl product (generic) under an e…