Shares of Alembic Pharmaceuticals Ltd were trading in the green and 3% higher on 2 August after the company announced securing final approval from the US Food and Drug Administration (USFDA) for the Nelarabine injection, which is used to treat cancer.

Alembic Pharma informed the exchanges that the US pharmaceutical regulator had approved its Abbreviated New Pharmaceutical Application (ANDA) for 250 mg/50 mL (5 mg/mL) single-dose vials of Nelarabine injection. Therapeutically speaking, the ANDA is equivalent to Sandoz Inc.’s reference-listed medication, Arranon.

Neragabine is used to treat patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma who have relapsed or have not responded to at least two chemotherapy regimens.

As stated in the petition, IQVIA estimates that the market for nelarabine injection will be worth $23 million for the 12-month period ending March 2024. 

According to Alembic, of the 211 FDA ANDA clearances obtained thus far, 183 are final, and the remaining 28 are provisional.

In June, the FDA granted provisional approval for the company’s injectable ANDA Selexipag to treat pulmonary arterial hypertension.

At 3:02 pm, the shares of Alembic Pharma were trading 2.31% higher at Rs 1,240.60 on NSE.

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