Amphastar's Naloxone Nasal Spray Delayed; User Human Factors Study Among FDA Concerns

FDA 'complete response' letter follows advisory committee's conclusion that the current naloxone approval standard is inadequate.

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FDA declined to approve Amphastar Pharmaceuticals Inc.'s new drug application for a nasal spray formulation of naloxone until the company addresses several issues with the opioid overdose reversal agent.

Amphastar announced on Feb. 21 that it had received a complete response letter (CRL) for its NDA from FDA that...

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