Alembic Pharma Celebrates FDA Nod for Nelarabine: Transforming the Future of Cancer Treatment!

Alembic Pharmaceuticals has announced that the US Food & Drug Administration (US FDA) has granted final approval for its abbreviated new drug application (ANDA) for Nelarabine Injection. This approval confirms that Alembic's Nelarabine Injection is therapeutically equivalent to the reference listed drug, Arranon Injection by Sandoz Inc. Nelarabine, a nucleoside metabolic inhibitor, is prescribed for treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. It is intended for both adult and pediatric patients aged 1 year and above whose conditions have either not responded to or have relapsed after at least two chemotherapy treatments.

According to IQVIA, Nelarabine Injection is projected to have a market size of approximately US$ 23 million for the twelve-month period ending in March 2024. Alembic Pharmaceuticals has received a total of 211 ANDA approvals from the US FDA, comprising 183 final approvals and 28 tentative approvals. As a vertically integrated research and development company, Alembic Pharmaceuticals produces and distributes generic pharmaceutical products globally.