Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Nelarabine Injection.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection of Sandoz Inc.
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Nelarabine Injection has an estimated market size of US$ 23 million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from US FDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.
The scrip rose 0.28% to currently trade at Rs 1219 on the BSE.
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