Alembic Pharma gets tentative USFDA nod for cancer drug Ivosidenib

Vadodara: Alembic Pharmaceuticals Limited has announced that the Company 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 isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: (a) Newly Diagnosed Acute Myeloid Leukemia (AML) 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.

Ivosidenib Tablets, 250 mg have an estimated market size of US$ 114 million for twelve months ending March 2024 according to IQVIA.

Alembic has a cumulative total of 207 ANDA approvals (179 final approvals and 28 tentative approvals) from USFDA.

Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA for its ANDA for Bosutinib Tablets, 100 mg and 500 mg. Bosutinib tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia. It is a type of cancer that affects the blood and bone marrow. It is characterized by the presence of a specific genetic abnormality known as the Philadelphia chromosome.

Headquartered in India, Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Its state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.