1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

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

 
• By Brenda Sandburg

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

FDA entrance sign 2016

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA

More from Agency Leadership