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Aurobindo Receives FDA Approval for Pirfenidone Tablets USP, 267 mg and 801 mg

Published: August 11, 2025

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Pirfenidone Tablets USP, 267 mg and 801 mg. Aurobindo Pharma’s Pirfenidone Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Esbriet Tablets manufactured by Genentech Inc. (a subsidiary of Hoffmann La Roche Inc.)

Pirfenidone Tablets are indicated for the treatment of:

  • Idiopathic pulmonary fibrosis (IPF).