Alembic Pharma Gets USFDA Approval for Generic Cancer Drug

New Delhi, Aug 2 (PTI) Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic drug for cancer treatment.

The company has received final approval from the US Food and Drug Administration (USFDA) for Nelarabine Injection (250 mg/50 mL) (5 mg/mL) single-dose vial, Alembic Pharmaceuticals said in a regulatory filing.

The approved company's product is therapeutically equivalent to Sandoz Inc's reference listed drug Arranon Injection, it added.

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 pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

According to IQVIA, Nelarabine Injection, 250 mg/50 mL has an estimated market size of USD 23 million for twelve months ending March 2024.

Alembic said it now has a cumulative total of 211 abbreviated new drug application (ANDA) approvals from the USFDA.

Shares of the company were trading 0.53 per cent up at Rs 1,222 apiece on the BSE.