Natco Pharma Limited and Lupin Limited have received U.S. FDA approval for NATCO's Abbreviated New Drug Application for Eribulin Mesylate Injection in 1 mg per 2 ml Single-Dose Vials. The injection at a concentration of 0.5 mg per ml is a generic equivalent of the reference listed drug Halaven Injection by 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. The drug is also approved for unresectable or metastatic liposarcoma in patients who have received a prior anthracycline-containing regimen.
The reference listed drug Halaven had estimated annual sales of USD 43.7 million in the United States, according to IQVIA MAT data for the 12 months ending April 2026. The approval was disclosed on June 3, 2026.
Natco Pharma develops and manufactures generic pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products. Nine manufacturing sites and two research and development facilities in India support its operations. The manufacturing facilities are approved by regulators including the U.S. FDA, Brazil ANVISA, Health Canada, and WHO, serving over 50 global markets.
Natco Pharma focuses on limited competition molecules in the United States and is a research and development oriented organization. Natco Pharma is a leading oncology player in the domestic targeted therapies market and is headquartered in Hyderabad, India.
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