Alembic Pharmaceuticals announces USFDA Final Approval for Nelarabine Injection, 250 mg/50 mL

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New DrugApplication (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. 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 1245.15 as compared to the previous close of Rs. 1215.60. The total number of shares traded during the day was 22006 in over 2644 trades.

The stock hit an intraday high of Rs. 1250.50 and intraday low of 1190.85. The net turnover during the day was Rs. 27060699.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval NelarabineInjection