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FDA/Panel Decisions

Lupin, Natco Receive FDA Approval For Eribulin Mesylate Injection

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Lupin (500257,LUPIN) and its alliance partner Natco Pharma announced the approval from the FDA for Natco's Abbreviated New Drug Application for Eribulin Mesylate Injection, 1 mg/2 mL Single-Dose Vials. 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.

The company noted that Eribulin Mesylate Injection, 1 mg/2 mL Single-Dose Vials is the bioequivalent to the reference listed drug Halaven Injection of Eisai.

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