Opioid Use Disorder
📧 Sign up to get email alerts when something new happens for Opioid Use Disorder.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2026-08-14FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Camber Pharmaceuticals, Inc.)
Supplemental approval for a generic buprenorphine/naloxone product by Camber Pharmaceuticals, Inc. (ANDA 219850).
-
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…
-
EMA approval · 2026-01-29EMA Authorised: Zubsolv (buprenorphine hydrochloride;naloxone hydrochloride dihydrate) — Accord Healthcare S.L.U.
The European Medicines Agency authorized Zubsolv, a fixed-dose buprenorphine/naloxone product, for opioid-related disorders; the marketing a…
-
FDA approval · 2026-01-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride submitted by VistaPharm, LLC.
-
FDA approval · 2025-12-29FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for buprenorphine hydrochloride by Par Health USA, LLC, under ANDA206586.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2025-12-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC.
-
FDA approval · 2025-12-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride by VistaPharm, LLC, enabling the marketing of the generic product in the…
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for a buprenorphine and naloxone product from Sun Pharmaceutical Industries, Inc., signifying ap…
-
FDA approval · 2025-12-22FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for METHADOSE (methadone hydrochloride) submitted by SpecGx LLC.
-
FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for methadone hydrochloride in a generic product by Hikma Pharmaceuticals USA Inc.
-
FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for Aurolife Pharma’s methadone hydrochloride product, enabling its marketing as a generic methadone…
-
FDA approval · 2025-12-22FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine extended-release) submitted by Indivior Inc.
-
FDA approval · 2025-12-22FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride with naloxone hydrochloride) submitted by Indivior, up…
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate (SpecGx LLC), indicating regula…
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application for a generic Buprenorphine HCl and Naloxone HCl product for the treatment of opioid use diso…
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for Rhodes Pharmaceuticals L.P.'s generic buprenorphine/naloxone product.
-
FDA approval · 2025-12-22FDA 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…
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Hikma Pharmaceuticals USA Inc. to market a buprenorphine hydrochloride and naloxone hydrochlorid…
-
FDA approval · 2025-12-22FDA Approved: BRIXADI — Supplemental Application (Braeburn Inc.)
The FDA approved a supplemental application for BRIXADI (buprenorphine) from Braeburn Inc., resulting in updated labeling and/or expanded in…
-
FDA approval · 2025-12-22FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for DISKETS (methadone hydrochloride) by Hikma Pharmaceuticals USA Inc. The approval expands the lab…
-
FDA approval · 2025-12-22FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.
-
FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
FDA approved a supplemental application for Methadone Hydrochloride from Camber Pharmaceuticals, Inc, updating the product’s regulatory stat…
-
FDA approval · 2025-12-22FDA 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/PAI Pharma. The combination is used for t…
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for buprenorphine from Sun Pharmaceutical Industries, Inc.
-
FDA approval · 2025-12-22FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc., expanding the availability of this generic…