Lupin and Natco Receive Approval from U.S. FDA for Eribulin Mesylate Injection

Global pharma major Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco) today announced the approval from the United States Food and Drug Administration (U.S. FDA) for Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (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).

Shares of Lupin Limited was last trading in BSE at Rs. 2261.05 as compared to the previous close of Rs. 2249.55. The total number of shares traded during the day was 24049 in over 2040 trades.

The stock hit an intraday high of Rs. 2275.00 and intraday low of 2234.00. The net turnover during the day was Rs. 54026762.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals NatcoPharma