Amphastar’s Forteo ANDA Hit With CRL As Wait Goes On
Forteo Has No Tangible Patent Protection But Complexity A Major Hurdle
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.
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Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.
Amphastar, Amneal and Aurobindo are among ANDA sponsors confirming USFDA approval for generic versions of Endo’s Vasostrict (vasopressin) 20 units/ml single-dose vial – as first mover Eagle Pharmaceuticals remains locked in patent-litigation proceedings with the originator.