Opioid Overdose
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-11-07FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved Baxter Healthcare Corporation's naloxone hydrochloride as a generic drug under an original ANDA. This approval makes the generi…
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FDA approval · 2022-07-29FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Par Health USA, LLC)
FDA approved Naloxone Hydrochloride as a generic product under an original application (ANDA 215964) by Par Health USA, LLC, for reversal of…
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FDA approval · 2022-06-21FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (AMERISOURCE BERGEN)
FDA approved an original (generic) naloxone hydrochloride product by AmerisourceBergen, enabling a generic option for reversing opioid overd…
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FDA approval · 2022-06-10FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s original application for naloxone hydrochloride, a generic product intended to reverse opioid …
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FDA approval · 2022-06-09FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Mylan Institutional LLC)
FDA approved Naloxone hydrochloride under an Original Application from Mylan Institutional LLC, establishing a generic naloxone product.
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FDA approval · 2022-02-28FDA Approved: NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR — Original Application (Kaleo, Inc.)
FDA approved Kaleo’s Naloxone hydrochloride auto-injector for rapid treatment of suspected opioid overdose (NALOXONE HYDROCHLORIDE INJECTION…
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CLINICAL_TRIALS trial_result · 2022-01-11Clinical Trial Update: Project OOPEN: Opioid Overdose Prevention, Education and Intervention [Phase 4]
Phase 4 clinical trial update for Project OOPEN addressing opioid overdose prevention, education and intervention; study completed with resu…
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FDA approval · 2021-11-17FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for Naloxone Hydrochloride submitted by Eugia US LLC. This action confirms regulatory approval r…
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FDA approval · 2021-10-15FDA Approved: ZIMHI — Original Application (ZMI Pharma Inc.)
FDA approved the original application for ZIMHI, a naloxone hydrochloride injection, by ZMI Pharma Inc., for emergency treatment of opioid o…
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CLINICAL_TRIALS research · 2021-07-07Clinical Trial Update: User Acceptability of a Device-Based Opioid Overdose Intervention
A completed clinical trial assessing user acceptability of a device-based intervention for opioid overdose prevention.
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FDA approval · 2021-04-29FDA Approved: KLOXXADO — Original Application (Hikma Specialty USA Inc.)
The FDA approved KLOXXADO (naloxone hydrochloride) through an original application by Hikma Specialty USA Inc. to reverse opioid overdoses.
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FDA approval · 2021-04-05FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for Naloxone Hydrochloride, a generic naloxone hydrochloride product.
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FDA approval · 2021-01-29FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved a generic naloxone hydrochloride product under Baxter's Original Application (ANDA 214785). This approval confirms a generic fo…
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FDA approval · 2021-01-14FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approved Naloxone hydrochloride under an Original Application by Eugia US LLC. This is a generic drug approval.
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CLINICAL_TRIALS trial_result · 2020-10-08Clinical Trial Update: Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital [Phase 3]
Phase 3 trial comparing naloxone nasal spray with naloxone injection for opioid overdoses outside the hospital has completed.
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FDA approval · 2020-08-06FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
The FDA approved a supplemental application for NARCAN (naloxone hydrochloride nasal spray) submitted by Emergent Devices Inc.
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FDA approval · 2020-03-16FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories, Inc.)
FDA approved Dr. Reddy's Laboratories' original application for naloxone hydrochloride (generic naloxone) as a approved drug product.
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FDA approval · 2019-11-04FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approves the original application for Naloxone Hydrochloride from Eugia US LLC (ANDA212456), a generic naloxone product.
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FDA approval · 2019-10-15FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approved naloxone hydrochloride under an Original Application by Eugia US LLC.
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FDA approval · 2019-09-23FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for NARCAN nasal naloxone from Emergent Devices Inc., expanding the approved nasal formulation for o…
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FDA approval · 2019-04-19FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a generic naloxone hydrochloride product from Teva Pharmaceuticals USA, Inc. under an original ANDA.
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CLINICAL_TRIALS trial_result · 2017-09-26Clinical Trial Update: Evaluation of a Computerized Opioid Overdose Prevention Program [NA]
This clinical trial update reports completion and posted results of a study evaluating a computerized opioid overdose prevention program, co…
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FDA approval · 2017-08-08FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
FDA approved the original application for a generic naloxone hydrochloride product by Somerset Therapeutics, LLC (ANDA 207633).
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FDA approval · 2017-07-26FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
FDA approved the original application for Naloxone Hydrochloride (generic) from Somerset Therapeutics, LLC.
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CLINICAL_TRIALS trial_result · 2017-02-03Clinical Trial Update: Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use [Phase 1]
A Phase 1 trial reports on the bioavailability of a new nasal naloxone formulation intended for prehospital use in opioid overdose scenarios…