NDA 216157, held by Global Blood Theraps. Voxelotor.
As of Nov 13, 2026, NDA 216157 (Oxbryta), held by Global Blood Theraps, was first approved by FDA on Dec 17, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2021 | Original applicationNew dosage form · Priority review | Approved |
| Aug 18, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Dec 17, 2021 | Original applicationNew dosage form · 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
