This approval marks a significant milestone for the company, indicating that its product is therapeutically equivalent to the reference listed Tibsovo Tablets, 250mg of Servier Pharmaceuticals.
Ivosidenib is a targeted therapy designed for patients with a specific IDH1 mutation, which can be detected using an FDA-approved test.
The medication is indicated for use in various patient groups, including those with newly diagnosed Acute Myeloid Leukemia (AML) who are over 75 years old or have other health conditions that prevent them from undergoing intensive chemotherapy.
It is also prescribed for adults with relapsed or refractory AML and those with advanced or metastatic Cholangiocarcinoma who have already received prior treatment.
According to data from IQVIA, Ivosidenib Tablets have an estimated market size of $114m for the 12 months ending March 2024.
This tentative approval adds to Alembic’s portfolio, which now includes a cumulative total of 207 ANDA approvals from the USFDA, comprising 179 final approvals and 28 tentative approvals.
Previously, Alembic received tentative USFDA approval for ANDA for Bosutinib Tablets in 100mg and 500mg dosages.
Like Ivosidenib, Bosutinib is a treatment for a specific type of leukemia, known as Philadelphia chromosome-positive chronic myelogenous leukemia.
The market size for these tablets is estimated at $275m for the same 12-month period.
Headquartered in India, the vertically integrated research and development pharmaceutical company Alembic Pharmaceuticals has been a key player in the global pharmaceutical industry since 1907.