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# Esbriet Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/esbriet-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143302

*Federal Register* notice: FDA has determined that Genentech’s Esbriet (pirfenidone) film coated tablets (534 mg) was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met. Esbriet is indicated for treating idiopathic pulmonary fibrosis. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-04/pdf/2019-00847.pdf?ref=fdaweb.com).