Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2020-01-22Clinical Trial Update: Injectable Pharmacotherapy for Opioid Use Disorders (IPOD) [Phase 3]
A Phase 3 clinical trial update for Injectable Pharmacotherapy for Opioid Use Disorders (IPOD) has completed with results posted.
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CLINICAL_TRIALS trial_result · 2019-11-14Clinical Trial Update: A Multiple Dose Opioid Challenge Study [Phase 2]
Phase 2 multiple-dose opioid challenge study completed for moderate to severe opioid use disorder; results posted in 2019.
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FDA approval · 2019-10-31FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) submitted by Indivior Inc.
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FDA approval · 2019-10-11FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride by VistaPharm, LLC.
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FDA approval · 2019-10-09FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for a generic methadone hydrochloride product from Hikma Pharmaceuticals USA Inc., granting marketin…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc., indicating regulatory approval to modi…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for a generic buprenorphine and naloxone product from PAI Holdings/PAI Pharma, authorizing the A…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for buprenorphine from Sun Pharmaceutical Industries, granting approval of the generic product.
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Sun Pharmaceutical Industries' buprenorphine and naloxone product. This action grants regulatory…
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FDA approval · 2019-10-09FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride, indicating regulatory clearance for the generic product from PAI Ho…
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FDA approval · 2019-10-08FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Lannett Company, Inc.
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FDA approval · 2019-10-08FDA 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 developed by …
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FDA approval · 2019-10-07FDA 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 · 2019-10-07FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) from Indivior Inc., indicating a supplemental approval for the…
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FDA approval · 2019-10-07FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for methadone hydrochloride by Mylan Institutional LLC, resulting in updates to the product labeling…
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FDA approval · 2019-10-07FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) from Orexo US, Inc.
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FDA approval · 2019-10-07FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.’s supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydr…
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FDA approval · 2019-10-07FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine extended-release injection) from Indivior Inc., resulting in update…
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FDA approval · 2019-10-07FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine submitted by Hikma Pharmaceuticals USA Inc., authorizing changes to an approved ge…
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FDA approval · 2019-10-02FDA Approved: METHADONE HYDROCHLORIDE — Original Application (SpecGx LLC)
FDA approved an original application for methadone hydrochloride from SpecGx LLC, resulting in a generic version of this opioid product.
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CLINICAL_TRIALS research · 2019-09-25Clinical Trial Update: EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use [NA]
A completed clinical trial evaluating an electronic health record-based communication strategy to promote safe opioid use; results posted in…
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FDA approval · 2019-09-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Buprenorphine and naloxone submitted by Actavis Pharma, Inc. The approval relates to a supplemen…
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FDA approval · 2019-09-23FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application to approve a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from S…
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FDA approval · 2019-09-23FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc., associated with an existing approved product.
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CLINICAL_TRIALS trial_result · 2019-09-12Clinical Trial Update: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray [Phase 2]
Phase 2 clinical trial investigating fast-acting naloxone nasal spray for gambling disorder and related opioid use conditions has completed.