Amphastar Pharmaceuticals subsidiary Armstrong Pharmaceuticals has received a complete response letter from the FDA in regard to its NDA for the Primatene Mist epinephrine inhaler, Amphastar has announced. The CRL said that the FDA would require an additional human factors validation study as well as label and packaging changes.
In 2014, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted against approval of Armstrong’s NDA for Primatene Mist HFA. That version of the inhaler did not have a dose counter. According to the company, the current version of Primatene Mist has a “built-in spray indicator” and replaces the original version’s glass canister with a metal canister.
Amphastar CEO Jack Zhang commented, “While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA during the post-action phase to address their concerns in the CRL by the middle of 2017 and bring Primatene Mist back to the OTC market as soon as possible.”
Read the Amphastar press release.
