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OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History

 
• By Malcolm Spicer

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

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Amphastar Pharmaceuticals Inc. says US FDA approval of its Primatene Mist OTC emergency asthma inhaler is worth everything it cost, starting with being off the market for seven years.

FDA's decisions to limit the approval to 160-dose containers and to require additional pediatric population testing also don't have Amphastar questioning its commitment to the product, which also withstood an advisory

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