NATCO and Lupin receive approval from U.S. FDA for Eribulin Mesylate Injection

NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") and its alliance partner Lupin Limited 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/2ml (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 Natco Pharma Limited was last trading in BSE at Rs. 935.80 as compared to the previous close of Rs. 939.10. The total number of shares traded during the day was 146098 in over 7264 trades.

The stock hit an intraday high of Rs. 942.50 and intraday low of 884.90. The net turnover during the day was Rs. 133230626.00.

Source : Equity Bulls

Keywords

NatcoPharma INE987B01026 Pharmaceuticals Lupin Approval USFDA EribulinMesylateInjection