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FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease
January 21, 2021 GMT
SOUTH SAN FRANCISCO, Calif. (BUSINESS WIRE) Jan 21, 2021
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet ® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.