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This Article is From Aug 25, 2023

Lupin Gets U.S. FDA Nod To Market Generic Drug

Lupin Gets U.S. FDA Nod To Market Generic Drug
Lupin's manufacturing site at Visakhapatnam. (Source: Company website)

Drug maker Lupin on Friday said it has received approval from the U.S. health regulator to market a generic product, used in the treatment of a lung disease, in the American market.

The company has received approval from the U.S. Food and Drug Administration to market Pirfenidone tablets in strengths of 267 mg and 801 mg, the Mumbai-based drug maker said in a statement.

The company's product is the generic equivalent of La Roche Inc's Esbriet tablets, it added.

Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis.

As per IQVIA MAT data, Pirfenidone tablets had estimated annual sales of $218 million in the U.S.

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