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Adamis Receives FDA Approval For 505(b)(2) Naloxone

Company Has Partnered With US WorldMeds To Launch Zimhi In Q1 2022

 
• By Akriti Seth

Adamis has announced receiving FDA approval for Zimhi, its high-dose naloxone hydrochloride for injection, indicated for the treatment of opioid overdose. The company has partnered with US WorldMeds to market Zimhi by the first quarter of 2022. 

Naloxone
Adamis receives approval for its hybrid naloxone for injection • Source: Alamy

Adamis Pharmaceuticals Corp. has received US Food and Drug Administration approval for its Zimhi 5mg/0.5ml naloxone hydrochloride for intramuscular or subcutaneous injection indicated for the treatment of opioid overdose.

Zimhi’s approval comes through the 505(b)(2) hybrid pathway, after Adamis previously received two complete response letters related to

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