Amphastar Pharmaceuticals, Inc.
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Latest From Amphastar Pharmaceuticals, Inc.
Amphastar will not be receiving approval in 2022 for its proposed generic version of Eli Lilly’s Forteo (teriparatide) peptide for the treatment of osteoporosis, after the FDA told the company it could not issue an approval at this stage.
Amphastar has become the fifth firm to receive FDA approval for generic regadenoson, but the exact launch date for the firm and its other generic competitors remains uncertain.
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.
In addition to epinephrine inhaler indicated for emergency use FDA currently allows for nonprescription access, a “positive step forward would be to make inhaled albuterol available OTC,” say researchers in a recent JAMA article.
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