Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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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…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from Spec…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
The FDA approved a supplemental application for buprenorphine and naloxone from Dr. Reddy's Laboratories.
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Buprenorphine and Naloxone from Mylan Pharmaceuticals. This expands the regulatory authoriza…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
FDA approved a supplemental application for Accord Healthcare's generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate pro…
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FDA approval · 2022-05-03FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) from Indivior Inc., typica…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc. under the ANDA, indicating changes to labeling or in…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for buprenorphine and naloxone to the existing product from PAI Holdings, supporting its use for…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Lannett's generic buprenorphine/naloxone product, enabling its use for the treatment of opio…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
The FDA approved a supplemental application for Buprenorphine and Naloxone Sublingual Film by Alvogen Inc., enabling a new manufacturing/for…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for the buprenorphine and naloxone product from Rhodes Pharmaceuticals L.P.
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Mylan Pharmaceuticals, supporting changes to the product's label…
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FDA approval · 2022-05-03FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's supplemental application for a buprenorphine/naloxone product (ANDA 201633) intended for the treatment…
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CLINICAL_TRIALS trial_result · 2022-04-27Clinical Trial Update: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up [Phase 2, Phase 3]
Phase 2/Phase 3 trial update comparing treatments for HIV-infected opioid users within an integrated care model (CHOICES) completed with res…
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CLINICAL_TRIALS trial_result · 2022-04-26Clinical Trial Update: Video-based, Patient-Focused Opioid Education in the Perioperative Period [NA]
A completed clinical trial evaluating video-based, patient-focused education for opioid use in the perioperative period; results posted in 2…
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CLINICAL_TRIALS trial_result · 2022-04-06Clinical Trial Update: Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults [NA]
A completed clinical trial evaluates a tailored opioid messaging program (STOMP) aimed at improving risk understanding in young adults.
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FDA approval · 2022-03-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, updating an existing ANDA product.
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CLINICAL_TRIALS trial_result · 2022-03-02Clinical Trial Update: Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol [Phase 2, Phase 3]
A clinical trial investigating buprenorphine as an adjunct to outpatient induction onto Vivitrol for opioid-use disorder was terminated, wit…
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CLINICAL_TRIALS trial_result · 2022-02-11Clinical Trial Update: Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers [Phase 4]
Phase 4 trial investigating the influence of THC on oxycodone-induced ventilatory depression in healthy volunteers.
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CLINICAL_TRIALS trial_result · 2022-02-10Clinical Trial Update: Slow-Release Oral Morphine for the Treatment of Opioid Use Disorder [Phase 3]
A Phase 3 trial evaluating slow-release oral morphine for opioid use disorder has been terminated.
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CLINICAL_TRIALS trial_result · 2022-01-12Clinical Trial Update: A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder [Phase 1]
Phase 1 study evaluating the impact of a single dose of ASP8062 on the safety, tolerability, and pharmacokinetics of buprenorphine/naloxone …