FDA gives Alembic tentative approval for generic Tibsovo

Alembic has received tentative approval from the Food and Drug Administration for Ivosidenib Tablets, 250 mg, which is the generic of Servier’s Tibsovo.

Ivosidenib is an isocitrate dehydrogenase-1 inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: (a) newly diagnosed Acute Myeloid Leukemia as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; (b) adult patients with Relapsed or refractory AML; (c) adult patients with Locally Advanced or Metastatic Cholangiocarcinoma who have been previously treated.

[Read more: Alembic releases generic Pradaxa]

Ivosidenib have a market value of roughly $114 million for the 12 months ending March 2024, per IQVIA.