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 · 2016-12-16FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) from Indivior, enabling an update to its labeling/indicati…
-
FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals LLC's supplemental application for a buprenorphine HCl and naloxone HCl product (generic) under an e…
-
FDA approval · 2016-12-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by Mylan Institutional LLC. The action may involve labelin…
-
FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride from Advagen Pharma Ltd, representing an approved amendment to an ex…
-
FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Actavis Pharma to manufacture and distribute a generic buprenorphine and naloxone product for op…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2016-12-16FDA 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 (PAI Holdings/PAI Pharma).
-
FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Hikma Pharmaceuticals' buprenorphine hydrochloride and naloxone hydrochloride dihydrate, exp…
-
FDA approval · 2016-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride by Hikma Pharmaceuticals USA Inc., granting regulatory clearance for…
-
FDA approval · 2016-12-09FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., indicating an updated indication or labeling via …
-
FDA approval · 2016-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approves a supplemental application for a buprenorphine and naloxone product manufactured by PAI Holdings for the treatment of opioid us…
-
FDA approval · 2016-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride by VistaPharm, LLC, enabling the generic product to be marketed. This ac…
-
FDA approval · 2016-10-28FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride (SpecGx LLC), confirming continued approval and availability of this gen…
-
FDA approval · 2016-10-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) by Orexo US, Inc.
-
FDA approval · 2016-09-30FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc.
-
FDA approval · 2016-09-30FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for a generic methadone hydrochloride product from VistaPharm, LLC. The drug is used for opioid use …
-
FDA approval · 2016-09-30FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for methadone hydrochloride from Aurolife Pharma, LLC, making a generic version of the drug availabl…
-
FDA approval · 2016-09-30FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for methadone hydrochloride from Epic Pharma, LLC.
-
FDA approval · 2016-09-30FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for a generic methadone hydrochloride product from Ascend Laboratories, LLC.
-
FDA approval · 2016-09-19FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Lannett Company, Inc.)
FDA approved a generic buprenorphine and naloxone product from Lannett Company (ANDA205022) under an original application, for the treatment…
-
FDA approval · 2016-08-05FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' generic buprenorphine and naloxone product under ANDA 201633.
-
FDA approval · 2016-07-07FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine (generic) filed by Hikma Pharmaceuticals USA Inc.; this covers an update to the ap…
-
FDA approval · 2016-07-07FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride (generic) from PAI Holdings, under ANDA 090622.
-
FDA approval · 2016-07-07FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' supplemental application for buprenorphine HCl and naloxone HCl (buprenorphine and naloxone). This acti…
-
FDA approval · 2016-07-07FDA 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 from PAI Holdings (PAI Pharma), marking an additional approval for th…
-
FDA approval · 2016-07-07FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) by Orexo US, Inc., updating its…