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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Glucagon And Epinephrine Continue To Drive Growth At Amphastar
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.
Multiple Vasostrict ANDAs Rival Eagle In Competitive Market
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.
Amphastar Receives FDA Approval For Regadenoson Following Solid Q1
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.