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Lupin, Natco get USFDA’s nod for Eribulin Mesylate Injection

03 Jun 2026 Evaluate

Lupin and its alliance partner Natco Pharma (Natco) have received the approval from the United States Food and Drug Administration (USFDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials.

Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is the bioequivalent to the reference listed drug (RLD) Halaven Injection of Eisai, Inc. Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease and unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. 

Eribulin Mesylate Injection (RLD Halaven) had estimated annual sales of $43.7 million in the U.S. (IQVIA MAT April 2026).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

Lupin Share Price

2248.70 -12.35 (-0.55%)
04-Jun-2026 16:59 View Price Chart
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