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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

 
• By Dean Rudge

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.

Red traffic light (Kurt Brady/Alamy Stock Photo)
Amphastar is now likely looking at 2023 • Source: Shutterstock (Kurt Brady / Alamy Stock Photo/Alamy Stock Photo)

Amphastar Pharmaceuticals is planning its response to the US Food and Drug Administration in September or October this year after its proposed substitutable generic version of Eli Lilly’s Forteo (teriparatide) received a complete response letter from the agency, communicating that the US firm’s abbreviated new drug application product cannot be approved in its current format.

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