Treats severe alopecia areata. NDA 217900, held by Sun Pharm Inds Inc. Deuruxolitinib Phosphate.
As of Nov 13, 2026, NDA 217900 (Leqselvi), held by Sun Pharm Inds Inc, was first approved by FDA on Jul 25, 2024, with 1 approved supplement and 0 published complete response letters.
LEQSELVI is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. LEQSELVI is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use: LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LeqselviEQ 8MG BASE · tablet;oral | Deuruxolitinib Phosphate | RxReference drug |
| Jun 30, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Jul 25, 2024 | Original applicationNew molecular entity · 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
