Alembic Pharmaceuticals Ltd. has received final approval from the US Food and Drug Administration for a single-dose vial of Nelarabine injection, which is used to treat leukemia, it said in a regulatory filing.
The drugmaker said that it now has a cumulative total of 211 abbreviated new drug application approvals from the US FDA.
According to global healthcare consultant IQVIA, the Nelarabine Injection has an estimated market size of $23 million for twelve months ending March 2024.
The company added that its US FDA-approved product is therapeutically equivalent to Sandoz Inc.'s reference listed drug Arranon Injection.
Nelarabine is a nucleoside metabolic inhibitor used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in patients aged one year and older. It is prescribed in cases where the disease has not responded to or has relapsed after at least two prior chemotherapy regimens.
Shares of the company were trading 2.43% up at Rs 1,245.15 apiece on the BSE, as compared to a 1.08% decline in the benchmark Sensex.
(With inputs from PTI)
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