. Adamis Pharmaceuticals Corporation announced that the FDA has approved Adamis' Zimhi (naloxone HCL Injection, USP) 5 mg/0.5 mL product. ZIMHI received approval through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. Adamis Pharmaceuticals has submitted an IND to the US Food and Drug Administration (FDA) for the use of Tempol to treat Covid-19. Adamis's Zimhi (naloxone HCL injection 5 mg/0.5 mL) has been approved as an additional high-dose countermeasure for opioid overdose. ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment . FDA Rejects High-Dose Naloxone Shot for Opioid Overdose REFERENCE. Adamis Receives FDA Approval for ZIMHI | ADMP Stock News Zimhi was approved through the 505 (b) (2) approval pathway that relied, in part, on the FDA's finding of safety and effectiveness for Opiant's Narcan (naloxone HCL injection), which had been previously approved as 0.4 mg and 2 mg doses. followed by approval of a 2 mg dose. ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. FDA approves naloxone injection to counteract opioid overdoses SAN DIEGO, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has approved Adamis' ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL product. Adamis receives FDA approval for ZIMHI [news release]. Adamis has obtained the Food and Drug Administration's blessing for Zimhi (naloxone HCL Injection) 5 mg/0.5 mL product. If naloxone hydrochloride ZIMHI is administered quickly, it can counter the opioid overdose effects within minutes. FDA Approvals Roundup: Tyrvaya, Zimhi, Biktarvy | RAPS SAN DIEGO, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has approved Adamis' ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL product. US WorldMeds and Adamis Pharmaceuticals Announce U.S. Launch of ZIMHI ... ZIMHI is designed to be administered in the muscle (intramuscular) or under the skin (subcutaneous) using a single-dose, prefilled syringe . You may report side effects to FDA at 1-800-FDA-1088. FDA has previously approved injectable naloxone hydrochloride products . FDA rejects Adamis opioid overdose therapy Zimhi ... - pharmaphorum
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