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Amphastar’s Forteo ANDA Hit With CRL As Wait Goes On

Forteo Has No Tangible Patent Protection But Complexity A Major Hurdle

Executive Summary

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 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.

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