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# FDA Accepts 2 Submissions for Sickle Cell Drug
- URL: https://www.fdaweb.com/fda-accepts-2-submissions-for-sickle-cell-drug/
- Published: 2021-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:13:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150088

FDA has accepted for priority review a Global Blood Therapeutics supplemental NDA for Oxbryta (voxelotor) for treating sickle cell disease (SCD) in children ages four to 11 years. A separate NDA was also accepted that is seeking approval for a new age-appropriate dispersible tablet dosage form suitable for pediatric patients.  

Oxbryta is described as a first-in-class therapy that directly targets hemoglobin polymerization, the root cause of red blood cell sickling in SCD. It is currently approved in a tablet dosage form to treat SCD in patients age 12 years and older. FDA set a user fee review action target date of 12/25.