Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for methadone hydrochloride (Epic Pharma, LLC), approving a generic product under the ANDA pathway.
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FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for METHADONE HYDROCHLORIDE from SpecGx LLC, confirming the generic product under ANDA 207537. This …
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FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., resulting in a generic product appr…
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FDA approval · 2025-12-22FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Elite Laboratories, Inc.)
FDA approved a supplemental application for methadone hydrochloride (generic) from Elite Laboratories, Inc.
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FDA approval · 2025-12-15FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic buprenorphine/naloxone product via an Original Application (ANDA).
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FDA approval · 2025-08-29FDA Approved: BRIXADI — Supplemental Application (Braeburn Inc.)
The FDA approved a supplemental application for BRIXADI (buprenorphine) by Braeburn Inc., resulting in updated labeling for the product.
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FDA approval · 2025-07-29FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for buprenorphine hydrochloride from Par Health USA, LLC, indicating approval of a generic product u…
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FDA approval · 2025-06-25FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., updating an approved prod…
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FDA approval · 2025-05-19FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) submitted by Indivior Inc., en…
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FDA approval · 2025-05-19FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) submitted by Orexo US, Inc.
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EMA approval · 2025-05-16EMA Authorised: Buprenorphine Neuraxpharm (buprenorphine hydrochloride) — Neuraxpharm Pharmaceuticals S.L.
The EMA authorised Buprenorphine Neuraxpharm (buprenorphine hydrochloride) for opioid-related disorders.
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FDA approval · 2025-05-05FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves the original application for Methadone Hydrochloride generic from Hikma Pharmaceuticals USA Inc., enabling a new generic formul…
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FDA approval · 2025-04-11FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
FDA approved a supplemental application for SUBLOCADE (buprenorphine) filed by Indivior Inc., resulting in changes to the product labeling.
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FDA approval · 2025-03-28FDA Approved: BRIXADI — Supplemental Application (Braeburn Inc.)
FDA approved a supplemental application for BRIXADI (buprenorphine) from Braeburn Inc., updating the labeling of this buprenorphine product.
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EMA approval · 2025-03-21EMA Authorised: Buvidal (buprenorphine) — Camurus AB
The EMA authorised Buvidal, a long-acting buprenorphine injection for opioid use disorder, with Camurus AB as the marketing authorization ho…
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FDA approval · 2025-02-24FDA Approved: LOFEXIDINE HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)
The FDA approved a generic lofexidine hydrochloride product from Novadoz Pharmaceuticals LLC under an Original Application to help alleviate…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for a buprenorphine and naloxone product manufactured by Mylan Pharmaceuticals Inc., expanding acces…
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FDA approval · 2025-02-21FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine extended-release injection) from Indivior Inc. The action relates t…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA supplemental approval for a generic buprenorphine/naloxone product from Dr. Reddy's Laboratories Inc.
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride (PAI Holdings) under an ANDA, reflecting an updated or additional fo…
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FDA approval · 2025-02-21FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride, naloxone hydrochloride) from Indivior Inc. to modify the …
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FDA approval · 2025-02-21FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc.
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett Company's buprenorphine and naloxone product, making a generic buprenorphine/naloxone op…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Buprenorphine HCl and Naloxone HCl from Amneal Pharmaceuticals LLC. The product is used for trea…
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FDA approval · 2025-02-21FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone from Actavis Pharma, Inc. This action supplements an existing regulat…