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Adamis Gets Another CRL For Opioid Overdose-Reversal Drug

 
• By Alaric DeArment

Adamis got its second complete response letter for Zimhi. While not apparently related to the first, it may complicate the company's outlook following a lackluster quarter.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered.
Adamis' Zimhi is a high-dose injection of the overdose-reversal drug naloxone. • Source: Shutterstock

For the second time, Adamis Pharmaceuticals Corp. has received a complete response letter from the US Food and Drug Administration for Zimhi (naloxone), its drug to treat opioid overdoses – and for the second time it was related to quality issues. Adamis has a history over the years of receiving multiple – though not necessarily interrelated – CRLs for its injectable products, and the latest one comes at a challenging time for the company.

Like the first letter, the new CRL relates to chemistry, manufacturing and controls, but on a different topic, the company...

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