Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone from Sun Pharmaceutical Industries, Inc. This action approves changes…
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic buprenorphine/naloxone product from Lannett Company, expanding access to this opioid-u…
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for buprenorphine from Rhodes Pharmaceuticals L.P. to an existing approved product.
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FDA approval · 2022-06-17FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine) submitted by Indivior Inc., resulting in updated labeling for the …
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from Hikm…
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for buprenorphine and naloxone from Rhodes Pharmaceuticals L.P., related to its regulatory appro…
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate from SpecGx LLC.
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride under an ANDA, indicating an additional approved formulation or use.
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
The FDA approved a supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate from Accord Healthcare, Inc…
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FDA approval · 2022-06-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a buprenorphine and naloxone product (buprenorphine hydrochloride and naloxone hydrochloride) ma…
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FDA approval · 2022-06-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for a Sun Pharmaceutical generic combination of buprenorphine and naloxone for treating opioid depen…
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FDA approval · 2022-06-14FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for a buprenorphine HCl and naloxone HCl product, providing a generic opt…
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FDA approval · 2022-06-14FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for a buprenorphine/naloxone product by Actavis Pharma, Inc. This approval makes a generic versi…
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FDA approval · 2022-06-14FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Hikma's buprenorphine hydrochloride and naloxone hydrochloride dihydrate product, updating the l…
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FDA approval · 2022-06-14FDA 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…
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FDA approval · 2022-06-13FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
The FDA approved a supplemental application for buprenorphine hydrochloride from Advagen Pharma Ltd, enabling an additional generic version …
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FDA approval · 2022-06-13FDA Approved: BUPRENORPHINE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for buprenorphine from Rhodes Pharmaceuticals L.P., indicating an update to the product's regulatory…
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FDA approval · 2022-06-13FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for buprenorphine and naloxone manufactured by Rhodes Pharmaceuticals L.P., a generic product us…
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FDA approval · 2022-06-02FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (INGENUS PHARMACEUTICALS, LLC)
FDA approved a generic buprenorphine and naloxone combination (Ingenus Pharmaceuticals) under ANDA212756 for the treatment of opioid use dis…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA granted approval of Dr. Reddy's supplemental application for buprenorphine/naloxone; this generic product is approved for the treatment …
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application to market a generic buprenorphine HCl and naloxone HCl product for opioid use disorder.
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FDA approval · 2022-05-03FDA 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 submitted by PAI Holdings/PAI Pharma, authorizing changes to the…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Hikma's buprenorphine hydrochloride and naloxone hydrochloride dihydrate, validating the gen…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride filed by Advagen Pharma Ltd, indicating an approval related to an ex…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA granted supplemental approval for buprenorphine from Sun Pharmaceutical Industries, approving changes to the approved product pursua…