NATCO and Lupin Achieve U.S. FDA Approval for Eribulin Mesylate Injection
Hyderabad, India (June 3, 2026): Natco Pharma Limited ("NATCO") and its alliance partner Lupin Limited announced that they have received approval from the United States Food and Drug Administration (U.S FDA) for NATCO's Abbreviated New Drug Application (ANDA) concerning Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) Single-Dose Vials.This development marks a significant milestone in the pharmaceutical sector as it relates to the treatment of specific cancers. The approved injection is bioequivalent to the reference listed drug (RLD) Halaven® Injection manufactured by Eisai, Inc.
The indication for Eribulin Mesylate Injection covers adults with metastatic breast cancer who have previously completed at least two chemotherapeutic regimens for treating metastatic disease. It also targets patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
The U.S FDA approval pertains to the ANDA of Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials. The estimated annual sales for the reference drug, Halaven®, in the U.S., were reported by IQVIA MAT April 2026 at USD 43.7 million.
NATCO Pharma Limited is a company focused on developing and distributing generic and branded pharmaceuticals. Its operations include manufacturing across multiple sites globally.
NATCOPHARM Stock Price Movement
Shares of Natco Pharma Limited are shedding value as of 11:20 AM, slipping to ₹890.9 after the stock plunges 5.15% in live trading. The equity has seen intense movement today, having traded within a range bounded by the day's high of ₹935.4 and low of ₹885.4, with over 1.14 million shares exchanged.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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