Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for buprenorphine and naloxone from Dr. Reddy's Laboratories. The approval supports continued use of…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc., granting approval for changes to an already-a…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride (ANDA090622) filed by PAI Holdings, LLC dba Pharmaceutical Associate…
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for Actavis Pharma's generic buprenorphine/naloxone product for the treatment of opioid dependen…
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FDA approval · 2018-10-31FDA 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 from PAI Holdings, LLC dba Pharmaceutical Associates, Inc. …
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FDA approval · 2018-10-31FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine submitted by Actavis Pharma, Inc. under ANDA090819. The action confirms approval o…
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FDA approval · 2018-10-26FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) submitted by INDIVIOR INC.
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CLINICAL_TRIALS trial_result · 2018-10-09Clinical Trial Update: Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use [Phase 4]
Phase 4 trial investigating continuation of buprenorphine/naloxone for opioid-use disorder and acute pain management.
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FDA approval · 2018-09-21FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., granting approval for this generic …
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FDA approval · 2018-09-21FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved VistaPharm's supplemental application for methadone hydrochloride, authorizing a supplemental generic product for manufacturing…
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FDA approval · 2018-09-18FDA Approved: METHADOSE DISPERSIBLE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for METHADOSE DISPERSIBLE (methadone hydrochloride) from SpecGx LLC under ANDA 074184.
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., enabling the generic formulatio…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. to support a generic methadone hydro…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for Methadone Hydrochloride from VistaPharm, LLC, granting approval of a generic Methadone Hydro…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC, approving the generic product for distribution…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Elite Laboratories, Inc.)
FDA approved a supplemental application for Elite Laboratories' methadone hydrochloride (ANDA 210484), authorizing its continued marketing a…
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FDA approval · 2018-09-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc.
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FDA approval · 2018-08-02FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Elite Laboratories, Inc.)
FDA approved an Original Application for a generic methadone hydrochloride product from Elite Laboratories, Inc. (ANDA210484).
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CLINICAL_TRIALS trial_result · 2018-07-30Clinical Trial Update: KCNH2 Polymorphisms on the QTc Interval in Kelantanese Malays Patients Receiving Methadone Maintenance Therapy (MMT)
This completed study from Universiti Sains Malaysia examined how KCNH2 (HERG) polymorphisms influence the QTc interval in Kelantanese Malay …
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CLINICAL_TRIALS trial_result · 2018-07-05Clinical Trial Update: Pioglitazone to Treat Opioid Withdrawal Symptoms [Phase 1]
Phase 1 trial update shows the pioglitazone study for treating opioid withdrawal symptoms was terminated; sponsor is NIDA.
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FDA approval · 2018-06-14FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved the original application for a generic buprenorphine and naloxone product manufactured by Dr. Reddy's Laboratories Inc. This ma…
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FDA approval · 2018-06-14FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' buprenorphine and naloxone generic combination for the treatment of opioid dependence (ANDA 205299).
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FDA approval · 2018-06-11FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) submitted by INDIVIOR INC., approving changes to the existing …
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FDA approval · 2018-05-16FDA Approved: LUCEMYRA — Original Application (USWM, LLC)
FDA approved LUCEMYRA (lofexidine hydrochloride) as an original NDA for reducing opioid withdrawal symptoms during detoxification.
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CLINICAL_TRIALS research · 2018-05-15Clinical Trial Update: The Staying Safe Intervention [NA]
This is an update on the Staying Safe Intervention trial related to Hepatitis C and opioid use; the phase and status are not specified.