Primatene Mist Reaches Target Stores, Amphastar Spends Behind Reaching $65M Sales Target
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.
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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.
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.
Concerns about safety prompt an FDA advisory panel to recommend against approving Armstrong Pharmaceutical’s NDA for an OTC emergency asthma inhaler. Concerns about device malfunction and about a potentially inaccurate dose indicator also influence the panel.