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Amphastar Receives FDA Complete Response Letter for Intranasal Naloxone

February 28, 2017

The FDA declined to approve Amphastar’s intranasal naxolone for use in emergencies to treat an opioid overdose, issuing the company a complete response letter (CRL).

According to Amphastar, the agency identified issues with the human factors study, device evaluation and other items in the NDA. In statement, the company CEO Jack Zhang said the drugmaker will continue to work the agency to address the concerns raised in the CRL.

Amphastar did not respond to a request for comment.

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