New Delhi: Alembic Pharmaceuticals announced on Friday that it has been granted approval from the US health regulator to sell a generic medication for treating cancer. Alembic Pharmaceuticals stated in a regulatory filing that the US Food and Drug Administration (USFDA) has granted final approval for Nelarabine Injection (250 mg/50 mL) (5 mg/mL) single-dose vial.
The company's accepted product is equal in terms of therapy to Sandoz Inc's Arranon Injection, according to the statement. Nelarabine is a drug used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in patients age 1 and older who have not responded to two chemotherapy treatments. IQVIA reports that Nelarabine Injection, 250 mg/50 mL is expected to reach a market size of USD 23 million by March 2024.
Alembic announced that they have received a total of 211 Abbreviated New Drug Application (ANDA) approvals from the USFDA. The company's shares were trading on the BSE at Rs 1,222 apiece, up by 0.53 per cent.
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