Lupin and Natco Receive US FDA Approval for Eribulin Mesylate Injection
Wednesday, June 03, 2026
Lupin Limited and its alliance partner Natco Pharma have received approval from the U.S. Food and Drug Administration (FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials.
The approved product is bioequivalent to Halaven Injection, marketed by Eisai, and will be available in the same strength and dosage form.
Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapy regimens for metastatic disease. It is also approved for the treatment of patients with unresectable or metastatic liposarcoma who have previously received an anthracycline-containing treatment regimen.
According to IQVIA data for the 12 months ending April 2026, Halaven Injection recorded estimated annual sales of approximately USD 43.7 million in the United States.
The approval expands the oncology portfolios of Lupin and Natco and strengthens their presence in the U.S. generic medicines market.
Source: prnewswire.com
