Alembic Pharmaceuticals (Alembic) today 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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection, 250 mg/50 mL (5 mg/mL), of Sandoz. Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in adult and paediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Refer label for a detailed indication.
Nelarabine Injection, 250 mg/50 mL 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 USFDA.