Alembic Pharmaceuticals secures USFDA’s final approval for Nelarabine Injection

02 Aug 2024 Evaluate

Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection, 250 mg/50 mL (5 mg/mL), 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, 250 mg/50 mL has an estimated market size of $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 USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.


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