Lupin Gets FDA Nod for Generic Crestor

Aug 03, 2017

The Hindu Business Line

India's Lupin has received final approval from the U.S. FDA to market Rosuvastatin Calcium tablets used for lowering high cholesterol.

The drug is a generic version of AstraZeneca and iPR Pharmaceuticals' Crestor tablets.

Last year, AstraZeneca unsuccessfully sued the FDA in an attempt to prevent the agency from approving any generic Crestor products before the drugmakers’s seven-year orphan drug exclusivity period on a rare-disease use expired in 2023.

According to the Hindu Business Line, Lupin has received U.S. FDA approvals for 221 products and has 147 product filings are pending approval.

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