Natco, Lupin Secure USFDA Nod for Generic Cancer Drug Eribulin Mesylate Injection
New Delhi: NATCO Pharma Limited and its alliance partner Lupin Limited has announced 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/2ml (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 USD 43.7 million in the U.S. (IQVIA MAT April 2026).
NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s different manufacturing facilities are approved by several leading regulatory authorities like U.S. FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.
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