Key Approval Details

  • NATCO Pharma Limited (Scrip Code: 524816, NSE: NATCOPHARM) and its alliance partner Lupin Limited received approval from the United States Food and Drug Administration (US FDA) for NATCO's Abbreviated New Drug Application (ANDA)
  • Approval granted for Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) Single-Dose Vials
  • Approval date: June 3, 2026
  • The product is bioequivalent to the reference listed drug (RLD) Halaven® Injection of Eisai, Inc.

Product Indications

Eribulin Mesylate Injection is indicated for:

  • Treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease
  • Treatment of adults with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen

Market Context

  • Reference drug Halaven® had estimated annual sales of USD 43.7 million in the U.S. market (IQVIA MAT April 2026)