Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-12-04FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for Methadone Hydrochloride by Ascend Laboratories, LLC under an ANDA. This action supplements t…
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FDA approval · 2023-09-27FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC, indicating approval of a supplemental submission f…
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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 · 2023-07-03FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine) from Indivior Inc., updating the product labeling to reflect the a…
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FDA approval · 2023-06-26FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for buprenorphine hydrochloride (generic buprenorphine HCl) submitted by PAI Holdings/PAI Pharma…
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FDA approval · 2023-06-26FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for buprenorphine and naloxone by Rhodes Pharmaceuticals L.P., supporting the continued use of this …
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FDA approval · 2023-06-26FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine and naloxone submitted by PAI Holdings (PAI Pharma).
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FDA approval · 2023-06-14FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc., indicating regulatory approval related to this generic …
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FDA approval · 2023-06-14FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from Spec…
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FDA approval · 2023-06-13FDA 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 · 2023-06-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic buprenorphine and naloxone product from Lannett Company, Inc.
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FDA approval · 2023-06-06FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from Hikma Pharma…
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FDA approval · 2023-06-05FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for buprenorphine.
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FDA approval · 2023-06-02FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone (buprenorphine/naloxone) from Sun Pharmaceutical Industries, Inc. und…
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FDA approval · 2023-05-25FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals LLC's supplemental application for a generic buprenorphine HCl and naloxone HCl product for the treatmen…
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FDA approval · 2023-05-23FDA Approved: BRIXADI — Original Application (Braeburn Inc.)
FDA approves BRIXADI (buprenorphine) from Braeburn Inc. under an original application to treat opioid use disorder; BRIXADI is an extended-r…
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FDA approval · 2023-05-23FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for buprenorphine and naloxone sublingual film by Alvogen Inc.
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FDA approval · 2023-03-23FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV, a buprenorphine/naloxone product from Orexo US, Inc.
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FDA approval · 2023-01-06FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine) from Indivior Inc., authorizing changes requested in the supplemen…
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FDA approval · 2022-12-16FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine/naloxone) submitted by Indivior Inc.
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for buprenorphine hydrochloride under an Abbreviated New Drug Application from PAI Holdings, LLC…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application for Buprenorphine HCl and Naloxone HCl (buprenorphine and naloxone).
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FDA approval · 2022-12-16FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) from Orexo US, Inc., updating i…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic buprenorphine and naloxone product from Lannett Company, expanding access to treatment…
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FDA approval · 2022-12-16FDA 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…