Lupin and Natco Receive Approval from U.S. FDA for Eribulin Mesylate Injection
Mumbai, India, Naples, Fla., June 03, 2026: Global pharma major Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco) today announced the approval from the United States Food and Drug Administration (U.S. FDA) 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 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 USD 43.7 million in the U.S. (IQVIA MAT April 2026).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn
https://www.linkedin.com/company/lupin
For further information or queries, please contact
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com
Elise Titan
Director – U.S. Communications, Lupin
elisetitan@lupin.com
*Safe Harbor Statement
Halaven® is a registered trademark of Eisai R&D Management Co., Ltd.
Latest Press Releases
Lupin Receives Tentative Approval from U.S. FDA for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets
Lupin Announces Closure of Inspection by U.S. FDA at its Somerset Facility with No Observations
Lupin Receives Approval from U.S. FDA for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06%
Close
Global Privacy Control Detected
We have detected your Global Privacy Control (GPC) signal. In accordance with applicable privacy laws, we have automatically honored your preference and disabled all non-essential cookies and tracking.
Only necessary cookies required for the website to function are enabled.
Opt-Out Request Honored
We have respected your privacy preference. Your opt-out request through cookie settings or Global Privacy Control signal has been honored.