Amphastar Has First US Glucagon Rival
FDA Approves First Generic Version Of Eli Lilly’s Glucagon Emergency Kit
Amphastar has secured the first US approval for a generic version of Eli Lilly’s glucagon emergency kit.
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Amphastar is celebrating what it says is its fourth injectable peptide product approval from the USFDA with its generic version of Organon’s ganirelix acetate, in the process setting up a rivalry with Sun Pharma and commercial partner Ferring Pharmaceuticals.
Amphastar has reported double-digit growth in the fourth quarter of 2021, as the company sees sales growth from Primatene Mist, epinephrine products and glucagon. The company also revealed that it is anticipating a Q3 FY22 launch of vasopressin.
Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.