Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments
This article was originally published in The Pink Sheet
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.
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CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.
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