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Natco Pharma, Lupin alliance secures U.S. FDA nod for generic breast cancer drug

Natco Pharma, Lupin alliance secures U.S. FDA nod for generic breast cancer drug

Posted on June 3, 2026 By admin


The U.S. Food and Drug Administration has approved Natco Pharma’s abbreviated new drug application (ANDA) for cancer drug Eribulin Mesylate Injection. File
| Photo Credit: Getty Images

The U.S. Food and Drug Administration (U.S FDA) has approved Natco Pharma’s abbreviated new drug application (ANDA) for cancer drug Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) single-dose vials, the generic drugmaker and its alliance partner Lupin said on Wednesday (June 3, 2026).

The approved product is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai Inc. The RLD (Halaven) had an estimated annual sales of $43.7 million in the U.S., the two companies said citing IQVIA MAT April 2026 numbers. Eribulin Mesylate injection is indicated for the treatment of adults with metastatic breast cancer.

Published – June 03, 2026 03:27 pm IST



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Business Tags:FDA nod for breast cancer drug, FDA nod for breast cancer drug by Natco, Lupin, Natco Lupin alliance, Natco Lupin alliance for cancer drug, Natco Lupin alliance secures FDA nod for breast cancer drug, Natco Lupin FDA nod for breast cancer drug, US FDA nod for cancer drug

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