Lupin, Natco receive US FDA approval for Eribulin Mesylate Injection
ANDA approval covers Eribulin Mesylate Injection, the bioequivalent of Halaven Injection, for metastatic breast cancer and liposarcoma treatment
Lupin and its alliance partner Natco Pharma have received approval from the United States Food and Drug Administration (US FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials.
According to the companies, Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is the bioequivalent of the reference listed drug (RLD), Halaven Injection of Eisai.
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 product is also indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
According to IQVIA MAT April 2026 data cited by the companies, Eribulin Mesylate Injection (RLD Halaven) recorded estimated annual sales of USD 43.7 million in the United States.