- FDA declines approval for Milestone Pharmaceuticals' etripamil nasal spray application.
- Issues cited involve chemistry, manufacturing, and control, necessitating a facility inspection.
- Additional data on nitrosamine impurities requested.
- No safety or efficacy concerns raised by the FDA.
- Positive results from late-stage study, demonstrating the efficacy of the self-administered nasal spray.
- Approximately 2 million people in the U.S. diagnosed with paroxysmal supraventricular tachycardia.
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