Opioid Overdose
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-08-05Clinical Trial Update: Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens [Phase 1]
Phase 1 pharmacokinetic study evaluating intranasal nalmefene across three dosing regimens.
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CLINICAL_TRIALS trial_result · 2024-06-26Clinical Trial Update: Nalox-Comm: Naloxone Communication Training for Pharmacists [NA]
A completed clinical trial evaluating Nalox-Comm, a Naloxone communication training program for pharmacists, with results posted in June 202…
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CLINICAL_TRIALS trial_result · 2024-06-21Clinical Trial Update: ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity
A completed clinical trial update for ARM-ED evaluating advanced respiratory monitoring in drug toxicity. The study focuses on respiratory f…
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CLINICAL_TRIALS research · 2024-06-07Clinical Trial Update: Improving Availability of Intranasal Naloxone [NA]
This clinical trial update describes efforts to improve access to intranasal naloxone for opioid overdose, sponsored by Hartford Hospital.
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FDA approval · 2024-04-23FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic naloxone hydrochloride product. Naloxone is used to treat op…
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FDA approval · 2024-04-19FDA Approved: REZENOPY — Original Application (Scienture LLC)
FDA approved REZENOPY (naloxone hydrochloride) from Scienture LLC under an Original New Drug Application. It is approved as an emergency rev…
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FDA approval · 2024-04-02FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's naloxone hydrochloride under an Original Application (ANDA), enabling the marketing of a generic …
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FDA approval · 2024-02-29FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)
FDA approved the Original Application for Naloxone Hydrochloride from Lifestar Pharma LLC, authorizing a generic naloxone product.
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FDA approval · 2023-11-15FDA Approved: NALMEFENE HYDROCHLORIDE — Original Application (Chengdu Shuode Pharmaceutical Co., Ltd)
FDA approved nalmefene hydrochloride injection from Chengdu Shuode Pharmaceutical Co., Ltd under an Original Application. This marks a gener…
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FDA approval · 2023-10-06FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (BPI Labs LLC)
FDA approved the original application for naloxone hydrochloride from BPI Labs LLC, making a generic naloxone product available for opioid o…
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FDA approval · 2023-10-05FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
The FDA granted a supplemental approval for naloxone hydrochloride from Par Health USA, LLC.
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FDA approval · 2023-07-28FDA Approved: RIVIVE — Original Application (Harm Reduction Therapeutics, Inc.)
FDA approved the original application for RIVIVE (naloxone hydrochloride) by Harm Reduction Therapeutics, Inc. for emergency reversal of opi…
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FDA approval · 2023-07-18FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (AMERISOURCE BERGEN)
The FDA approved a supplemental application for naloxone hydrochloride from AmerisourceBergen, enabling a generic naloxone product to be mar…
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CLINICAL_TRIALS withdrawal · 2023-07-12Clinical Trial Update: Clinical Outcomes From Nalmefene [Phase 4]
A Phase 4 clinical trial evaluating nalmefene for opioid overdose has been withdrawn.
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FDA approval · 2023-06-29FDA Approved: REXTOVY — Supplemental Application (International Medication Systems, Ltd.)
The FDA approved a supplemental application for REXTOVY (naloxone hydrochloride) filed by International Medication Systems, Ltd. The action …
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FDA approval · 2023-06-02FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for Naloxone Hydrochloride from Eugia US LLC under ANDA 213279, granting approval of the generic pro…
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FDA approval · 2023-05-31FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for Naloxone hydrochloride from Hospira, a generic opioid antagonist.
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FDA approval · 2023-05-16FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for naloxone hydrochloride from Par Health USA, LLC under ANDA215964. The action confirms approval o…
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FDA approval · 2023-05-16FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (International Medication Systems, Limited)
FDA approved a supplemental application for naloxone hydrochloride from International Medication Systems, Limited.
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FDA approval · 2023-05-15FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naloxone hydrochloride by Hikma Pharmaceuticals USA Inc., approving an updated regulatory action…
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CLINICAL_TRIALS trial_result · 2023-05-06Clinical Trial Update: Rapid Initiation of Drug Treatment Engagement [Phase 4]
Phase 4 clinical trial on rapid initiation of drug treatment engagement for opioid use disorder; results have been posted.
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FDA approval · 2023-04-03FDA Approved: NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR — Supplemental Application (Kaleo, Inc.)
FDA approved Kaleo, Inc.'s supplemental application for Naloxone Hydrochloride Injection, USP, Auto-Injector. The product is intended for em…
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FDA approval · 2023-03-29FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for Narcan nasal naloxone, submitted by Emergent Devices Inc., for the nasal naloxone product.
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FDA approval · 2023-03-27FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for Narcan nasal naloxone from Emergent Devices Inc., approving an addition to the already approved …
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FDA approval · 2023-03-07FDA Approved: REXTOVY — Original Application (International Medication Systems, Ltd.)
The FDA approved REXTOVY (naloxone hydrochloride) through the original NDA from International Medication Systems, Ltd., marking its first ap…