Hyderabad-based Natco, Lupin secure USFDA nod for generic breast cancer treatment

Lupin and Hyderabad-based Natco Pharma have received USFDA approval for Eribulin Mesylate Injection, a generic version of Halaven used to treat metastatic breast cancer and advanced liposarcoma. The reference drug recorded annual US sales of approximately $43.7 million.

Hyderabad: Global pharma major Lupin Limited and its alliance partner, Hyderabad-based Natco Pharma Limited (Natco), on Wednesday announced the USFDA approval for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials for breast cancer.

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.

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Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent to the reference listed drug (RLD) Halaven Injection of Eisai, Inc. Eribulin Mesylate Injection (RLD Halaven) had estimated annual sales of USD 43.7 million in the US, a press release added.