OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
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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