OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History
This article was originally published in The Pink Sheet & The Rose Sheet
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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Sales of Primatene Mist and other higher-margin products drive Amphastar's ifrst-quarter r5esults. The company continues to target a combined market worth around $10.5bn with seven generics in development.
In addition to distributing to Target stores, TV, radio and digital advertising and late-2020 start of sales at Kroger stores are driving Primatene Mist sales growth. The epinephrine aerosol inhaler's sales increased 186% in 2020 to $51.7m and 47% in Q4 to $13.4m.
"Manufacturers are already working on possible solutions to address the concerns and will work with the Agency to implement any appropriate measures,” says CHPA senior VP Barbara Kochanowski.