Treats sickle cell disease (SCD). NDA 213137, held by Global Blood Theraps. Voxelotor.
As of Nov 13, 2026, NDA 213137 (Oxbryta), held by Global Blood Theraps, was first approved by FDA on Nov 25, 2019, with 2 approved supplements and 0 published complete response letters.
OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
| Dec 17, 2021 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Nov 25, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Aug 18, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Dec 17, 2021 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Nov 25, 2019 | Original applicationNew molecular entity · 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
