Will Primatene Mist Inventory Ever Leave The Warehouse?
Amphastar has inventory for the emergency asthma product but is frustrated by the recent second complete response letter from US FDA seeking additional information. Human factors issued figured into CRLs for both Primatene Mist and intranasal naloxone.
You may also be interested in...
Amphastar's Naloxone Nasal Spray Delayed; User Human Factors Study Among FDA Concerns
FDA 'complete response' letter follows advisory committee's conclusion that the current naloxone approval standard is inadequate.
Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments
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.
Higher Naloxone Doses Narrowly Favored By FDA Panel
Divided advisory committee concludes the current naloxone approval standard is inadequate due in part to increase in overdoses from powerful synthetic opioids, but doesn't offer FDA a clear alternative.