Alembic Pharmaceuticals Ltd has received the final approval from the US Food & Drug Administration (USFDA) Nelarabine injection used in cancer treatment.
Alembic Pharma’s Abbreviated New Drug Application (ANDA) for Nelarabine injection, 250 mg/50 mL (5 mg/mL) single-dose vials have been approved by the US drug regulator, the company informed the exchanges. The ANDA is therapeutically equivalent of the reference listed drug Arranon by Sandoz Inc.
Nelarabine is used in treating T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in patients who do not respond or have relapsed after at least two chemotherapy regimens.
The filing mentions that the market size for Nelarabine injection is estimated at $23 million for the 12-months ending March 2024, according to IQVIA. Alembic now has a total of 211 ANDA approvals (183 final and 28 tentative) from the FDA, the company said.
In June, the company hot FDA’s tentative approval for its ANDA Selexipag injection for treating pulmonary arterial hypertension.
At 12.14 pm, Alembic Pharma was trading at Rs 1,216.35 on the National Stock Exchange, up 0.32 percent from the previous close.
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