Alcohol Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-12-22FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.
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FDA approval · 2025-09-18FDA Approved: ACAMPROSATE CALCIUM — Original Application (Bionpharma Inc.,)
FDA approved the original application for a generic acamprosate calcium product from Bionpharma Inc., authorizing a generic version to help …
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FDA approval · 2024-08-07FDA Approved: ZURNAI — Original Application (Purdue Pharma L.P.)
FDA approved ZURNAI (nalmefene hydrochloride) via an original NDA from Purdue Pharma L.P. for the treatment of alcohol use disorder.
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FDA approval · 2023-05-22FDA Approved: OPVEE — Original Application (Indivior Inc.)
The FDA approved OPVEE (nalmefene hydrochloride) from Indivior as a new drug via an original NDA; it is indicated for the treatment of alcoh…
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FDA approval · 2021-11-02FDA Approved: DISULFIRAM — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for disulfiram from Chartwell RX, LLC, enabling a generic version of the alcohol-aversive drug to be…
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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 · 2021-03-04FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.
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FDA approval · 2020-05-08FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, Inc., updating the product labeling.
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FDA approval · 2019-06-07FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, Inc.
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FDA approval · 2018-12-28FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., authorizing changes to the product's labeling under a…
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FDA approval · 2017-05-26FDA Approved: ACAMPROSATE CALCIUM — Original Application (Zydus Lifesciences Limited)
FDA approves the original application for acamprosate calcium from Zydus Lifesciences Limited to market a generic product for maintaining ab…
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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 …
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FDA approval · 2016-12-06FDA Approved: DISULFIRAM — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application for Disulfiram (DISULFIRAM) submitted by Sigmapharm Laboratories, LLC. The notice does not specify t…
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FDA approval · 2016-05-20FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc. This action represents a supplemental approval relat…
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FDA approval · 2015-12-08FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., approving changes to labeling and expanding its i…
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FDA approval · 2015-07-22FDA Approved: NALTREXONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for naltrexone hydrochloride from Sun Pharmaceutical Industries, Inc., updating an existing gene…
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FDA approval · 2015-05-14FDA Approved: NALTREXONE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for naltrexone hydrochloride by Accord Healthcare, Inc., authorizing a new generic product.
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FDA approval · 2014-08-29FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, potentially expanding its labeling or indicatio…
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FDA approval · 2014-04-17FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, Inc.
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FDA approval · 2014-03-11FDA Approved: ACAMPROSATE CALCIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the original application for acamprosate calcium enteric-coated (generic), manufactured by Mylan Pharmaceuticals Inc. for the t…
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FDA approval · 2013-08-08FDA Approved: DISULFIRAM — Original Application (Alvogen Inc.)
FDA approved Disulfiram from Alvogen Inc. as an original generic application for the treatment of alcohol dependence/alcohol use disorder.
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FDA approval · 2013-07-16FDA Approved: ACAMPROSATE CALCIUM — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's generic acamprosate calcium tablets for the maintenance of abstinence in adults with alcohol use disorder.
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FDA approval · 2012-12-31FDA Approved: DISULFIRAM — Original Application (Chartwell RX, LLC)
The FDA approved Chartwell RX, LLC's original generic application for disulfiram, enabling a generic product for the treatment of alcohol us…
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EMA approval · 2012-12-14European Medicines Agency recommends approval of medicine for reduction of alcohol consumption
The EMA recommends approval of a medicine aimed at reducing alcohol consumption, indicating regulatory support for a new treatment option to…
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FDA approval · 2012-02-24FDA Approved: NALTREXONE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' original application for a generic naltrexone hydrochloride product. The approval covers indicat…