Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-05-03FDA 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 · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
The FDA approved a supplemental application for buprenorphine and naloxone from Dr. Reddy's Laboratories.
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Buprenorphine and Naloxone from Mylan Pharmaceuticals. This expands the regulatory authoriza…
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FDA approval · 2022-05-03FDA 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 · 2022-05-03FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) from Indivior Inc., typica…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc. under the ANDA, indicating changes to labeling or in…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for buprenorphine and naloxone to the existing product from PAI Holdings, supporting its use for…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Lannett's generic buprenorphine/naloxone product, enabling its use for the treatment of opio…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
The FDA approved a supplemental application for Buprenorphine and Naloxone Sublingual Film by Alvogen Inc., enabling a new manufacturing/for…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for the buprenorphine and naloxone product from Rhodes Pharmaceuticals L.P.
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Mylan Pharmaceuticals, supporting changes to the product's label…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's supplemental application for a buprenorphine/naloxone product (ANDA 201633) intended for the treatment…
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FDA approval · 2022-03-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, updating an existing ANDA product.
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FDA approval · 2021-11-24FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc., granting approval for this generic produc…
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FDA approval · 2021-11-24FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Lannett Company, Inc., confirming the availability of this gener…
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FDA approval · 2021-11-19FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine/naloxone) submitted by Indivior Inc.
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FDA approval · 2021-09-23FDA Approved: BUPRENORPHINE — Original Application (INGENUS PHARMACEUTICALS, LLC)
FDA approved a generic buprenorphine product from Ingenus Pharmaceuticals under the original ANDA application (ANDA210272).
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FDA approval · 2021-09-13FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadose (methadone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2021-08-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Buprenorphine and Naloxone from Sun Pharmaceutical Industries, Inc., updating the product's …
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FDA approval · 2021-06-17FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
FDA approved a supplemental application for SUBLOCADE (buprenorphine) by Indivior Inc., updating/expanding its labeling for the treatment of…
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FDA approval · 2021-06-02FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for METHADOSE (methadone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2021-06-02FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for DISKETS (methadone hydrochloride) filed by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for methadone hydrochloride from Mylan Institutional LLC, indicating an update to the product's labe…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
The FDA approved a supplemental application for methadone hydrochloride from Camber Pharmaceuticals, Inc., confirming approval for this gene…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, confirming approval of a generic methadone hydrochlorid…