
USFDA3 Jun 2026, 11:04 am
Lupin & Natco Get US FDA Nod for Eribulin Mesylate Injection
AI Summary
Lupin Limited and its alliance partner Natco Pharma Limited have received approval from the U.S. FDA for Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection. This injection is a bioequivalent to Halaven® Injection and is indicated for treating metastatic breast cancer and liposarcoma. The U.S. market for the reference drug had estimated annual sales of USD 43.7 million in April 2026. This approval marks a significant step for both companies in expanding their oncology product offerings in the U.S. market.
Key Highlights
- US FDA approval granted for Eribulin Mesylate Injection.
- Product is indicated for metastatic breast cancer and liposarcoma.
- Reference drug had US sales of $43.7 million in April 2026.
- Approval obtained by Lupin and alliance partner Natco Pharma.
Price Impact
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