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.
Comments
0 comment