Posted by Michael Wonder on 07 Sep 2021
U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11
7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review.
Global Blood Therapeutics today announced that the U.S. FDA has accepted for filing and review the company’s supplemental new drug application seeking accelerated approval for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11 years and its new drug application seeking approval for a new age-appropriate dispersible tablet dosage form of Oxbryta suitable for paediatric patients.
