Natco Pharma and Lupin Win USFDA Approval for Generic Breast Cancer Drug

On Wednesday, June 3, 2026, global pharmaceutical major Lupin Limited and its alliance partner, Hyderabad-based Natco Pharma Limited, announced that they have secured approval from the United States Food and Drug Administration (USFDA) for a generic breast cancer treatment.

The regulatory approval was granted for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials. The approved product is a generic version of Eisai, Inc.’s Halaven Injection, which serves as the reference listed drug.

Eribulin Mesylate Injection is indicated for adult patients suffering from metastatic breast cancer. Specifically, the treatment is designed for patients who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.

In addition to breast cancer, the USFDA approval covers the treatment of adult patients with unresectable or metastatic liposarcoma. This indication is designated for patients who have already received a prior anthracycline-containing regimen.

According to a press release issued by the companies, the newly approved Eribulin Mesylate Injection is bioequivalent to the reference listed drug, Halaven Injection. The reference drug, Halaven, recorded estimated annual sales of approximately USD 43.7 million in the United States.

The approval brings a new generic alternative to the United States market for patients requiring treatment for metastatic breast cancer and advanced liposarcoma. The collaboration between Lupin Limited and the Hyderabad-based Natco Pharma Limited highlights the successful regulatory review of the ANDA, allowing the partner firms to distribute the generic injection in the US.

With the USFDA nod secured, the alliance can now proceed with their plans for the generic injection, which matches the 1 mg/2 mL (0.5 mg/mL) single-dose vial presentation of the reference drug.