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Halaven Approval History

  • FDA approved: Yes (First approved November 15th, 2010)
  • Brand name: Halaven
  • Generic name: eribulin mesylate
  • Dosage form: Injection
  • Company: Eisai Co., Ltd.

Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer, and liposarcoma.

Breast Cancer; Liposarcoma

Development History and FDA Approval Process for Halaven

Jan 28, 2016Approval FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma
Nov 15, 2010Approval FDA Approves Halaven for Late-Stage Breast Cancer
Aug 30, 2010Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate
Mar 31, 2010Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU
Feb  1, 2008Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application

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