Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone from Sun Pharmaceutical Industries, updating the product's labeling.
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for Alvogen's buprenorphine/naloxone sublingual film, enabling the generic product to be marketed fo…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for a generic buprenorphine/naloxone product from Rhodes Pharmaceuticals L.P. The approval confi…
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FDA approval · 2025-02-21FDA 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 intended for the treatment of opioid dependence, su…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for buprenorphine submitted by Sun Pharmaceutical Industries, Inc.
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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 · 2025-02-21FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc. under the approved ANDA.
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for Hikma's buprenorphine hydrochloride and naloxone hydrochloride dihydrate product for opioid use …
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (INGENUS PHARMACEUTICALS, LLC)
FDA approved a supplemental application for buprenorphine and naloxone from Ingenus Pharmaceuticals, LLC, for this combination product.
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for Buprenorphine and Naloxone from Dr. Reddy's Laboratories Inc. The approval indicates an update t…
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FDA approval · 2025-02-21FDA 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, enabling con…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., granting approval for the gener…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Elite Laboratories, Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Elite Laboratories, Inc., under an ANDA. This action updates th…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
FDA approved Camber Pharmaceuticals' supplemental application for methadone hydrochloride, a generic product. This confirms regulatory clear…
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FDA approval · 2024-10-31FDA Approved: BUPRENORPHINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for buprenorphine submitted by Teva Pharmaceuticals USA, Inc., indicating an approved update to …
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., authorizing changes under the appro…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride (generic), enabling continued marketing of the product.
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FDA approval · 2024-10-31FDA Approved: BUPRENORPHINE — Supplemental Application (INGENUS PHARMACEUTICALS, LLC)
The FDA approved a supplemental application for buprenorphine from Ingenus Pharmaceuticals, granting approval of a generic buprenorphine pro…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approves SpecGx LLC's supplemental application for methadone hydrochloride.
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., supporting its continued availabili…
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FDA approval · 2024-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., confirming the generic product's ap…
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FDA approval · 2024-10-10FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (INGENUS PHARMACEUTICALS, LLC)
FDA approved a supplemental application for buprenorphine and naloxone from Ingenus Pharmaceuticals under ANDA212756.
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FDA approval · 2024-08-27FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC.
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FDA approval · 2024-08-20FDA Approved: LOFEXIDINE — Original Application (Florida Pharmaceutical Products, LLC)
FDA approves lofexidine under an Original Application for Florida Pharmaceutical Products, LLC, enabling marketing of this generic lofexidin…
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EMA approval · 2024-07-29EMA Authorised: Suboxone (buprenorphine;naloxone) — Indivior Europe Limited
EMA has authorised Suboxone (buprenorphine/naloxone) for opioid-related disorders, with Indivior Europe Limited as the marketing authorizati…