Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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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…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. (ANDA 087393), granting approval of …
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
The FDA approved a supplemental application for methadone hydrochloride from Aurolife Pharma, LLC, enabling the generic product to be market…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride (generic methadone) submitted by VistaPharm, LLC under ANDA204166.
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride (generic) submitted by Hikma Pharmaceuticals USA Inc.
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CLINICAL_TRIALS trial_result · 2021-06-01Clinical Trial Update: Methadone vs. Fentanyl Administration on Postoperative Pain Control in Pediatric Patients Undergoing Cardiac Surgery [NA]
A terminated pediatric trial comparing methadone versus fentanyl for postoperative pain control in cardiac surgery; results posted in 2021.
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CLINICAL_TRIALS trial_result · 2021-05-25Clinical Trial Update: mHealth for Patient Self-Management of Opioid Use Disorder
A completed clinical trial exploring mHealth tools for patient self-management of opioid use disorder; results posted in 2021.
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FDA approval · 2021-05-06FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc.
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FDA approval · 2021-04-28FDA Approved: BUPRENORPHINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for buprenorphine from Teva Pharmaceuticals USA, Inc. under ANDA204937.
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CLINICAL_TRIALS trial_result · 2021-04-12Clinical Trial Update: Evaluation of Doxazosin to Alter the Abuse of Oxycodone [Phase 2]
Phase 2 trial evaluating doxazosin to alter abuse of oxycodone in opioid-use disorder ended (terminated) with results posted.
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FDA approval · 2021-03-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental ANDA for a generic buprenorphine and naloxone product, manufactured by PAI Holdings, LLC dba Pharmaceutical …
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CLINICAL_TRIALS trial_result · 2021-03-09Clinical Trial Update: An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder [Phase 1, Phase 2]
Open-label pilot study evaluating Sublocade (buprenorphine extended-release) for opioid-use disorder; completed with results posted in 2021.
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FDA approval · 2021-03-04FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.
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FDA approval · 2021-03-04FDA 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.
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Hikma Pharmaceuticals USA Inc. for buprenorphine hydrochloride and naloxone hydrochloride di…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride filed by Advagen Pharma Ltd under the ANDA, authorizing changes to t…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's supplemental application for a buprenorphine and naloxone product under an ANDA, making a generic vers…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application from Lannett Company for buprenorphine and naloxone, adding a supplemental approval for a generic pr…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for buprenorphine submitted by Rhodes Pharmaceuticals L.P.
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride from PAI Holdings/PAI Pharma, enabling the generic product to be mar…
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FDA approval · 2021-03-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc. The approval covers changes to labeling and…