In its 25th meeting held on 06.08.2025 at CDSCO Headquarters, New Delhi, the Subject Expert Committee (SEC) on Oncology recommended approval for Dr. Reddy’s Laboratories to import and market Olutasidenib Capsules.
US Food and Drug Administration (FDA) approved olutasidenib capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.