Alembic Nelarabine injection gets FDA final approval, ET HealthWorld

Mumbai: Alembic Pharmaceuticals Limited (Alembic) announced that it 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 pharma company informed that 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.

According to IQVIA, Nelarabine Injection, 250 mg/50 mL has an estimated market size of US$ 23 million for 12 months ending March 2024, it added.

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 one year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.