Alembic Pharma announces US FDA tentative approval for Ivosidenib tablets 250 mg
Alembic Pharmaceuticals (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals LLC.Ivosidenib is an inhibitor of isocitrate dehydrogenase-1 (IDH1) recommended for patients with susceptible IDH1 mutations found by an FDA-approved test for the following conditions: (a) newly diagnosed acute myeloid leukemia (AML) in adults 75 years of age or older as monotherapy, or in patients with comorbidities that prohibit intensive induction chemotherapy. (b) Adult AML patients who have relapsed or are resistant. (c) Adult patients who have received prior treatment and have locally progressed or metastatic cholangiocarcinoma. According to IQVIA, the market for 250 mg Ivosidenib tablets is expected to be worth USD 114 million by the end of March 2024. Alembic has received 207 ANDA approvals in total from the USFDA (179 final approvals and 28 tentative clearances).
