Treats idiopathic pulmonary fibrosis (IPF). NDA 208780, held by Legacy. Pirfenidone.
As of Nov 13, 2026, NDA 208780 (Esbriet), held by Legacy, was first approved by FDA on Jan 11, 2017, with 3 approved supplements and 0 published complete response letters.
ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Esbriet267MG · tablet;oral | Pirfenidone | RxReference drug |
| Esbriet534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pirfenidone | DiscontinuedReference drug |
| Esbriet801MG · tablet;oral | Pirfenidone | RxReference drug |
| Feb 24, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Feb 11, 2022 | Supplement 5Labeling · Standard review | Approved | |
| Jul 31, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Jan 11, 2017 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
