NDA 221291, held by Bayer Healthcare.
As of Nov 13, 2026, NDA 221291, held by Bayer Healthcare, was first approved by FDA on Nov 9, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2026 | Original applicationNew molecular entity ยท Priority 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
