Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial
This article was originally published in The Pink Sheet & The Rose Sheet
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.
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"We will begin TV advertising campaign in July, which we think will really increase awareness of the product and hopefully give a good return on investment on those commercials," says Amphastar president Jason Shandell. Returning recently relaunched product to Walmart,later in 2019 "should be a big boost for us because that was over 35% of sales previously," says CFO William Peters.
Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.