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Lusedra Approval History

  • FDA approved: Yes (First approved December 12th, 2008)
  • Brand name: Lusedra
  • Generic name: fospropofol disodium
  • Dosage form: Injection
  • Previous name: Aquavan
  • Company: Eisai Corporation of North America
  • Treatment for: Sedation

Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Development History and FDA Approval Process for Lusedra

Dec 15, 2008Approval FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
Jul 28, 2008Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures
Dec 17, 2007MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA
Sep 27, 2007MGI Pharma Announces Submission of Aquavan NDA

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