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Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

 
• By Malcolm Spicer

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.

Young Doctor With Digital Tablet

Amphastar Pharmaceuticals Inc. expects by July to try again with a new drug application to FDA to relaunch Primatene Mist OTC emergency asthma inhaler after receiving an agency "green light" on a clinical trial.

Amphastar received a general advice letter from FDA on its planned clinical trial to support an NDA for Primatene Mist...

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