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Cleviprex Approval History

  • FDA approved: Yes (First approved August 1st, 2008)
  • Brand name: Cleviprex
  • Generic name: clevidipine butyrate
  • Dosage form: Injectable Emulsion
  • Company: The Medicines Company
  • Treatment for: High Blood Pressure

Cleviprex (clevidipine) is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.

Development History and FDA Approval Process for Cleviprex

Aug  4, 2008Approval The Medicines Company‚Äôs Cleviprex Receives FDA Approval
Sep 14, 2007FDA Accepts NDA Filing for Cleviprex (Clevidipine Butyrate Injectable Emulsion) for the Treatment of Acute Hypertension

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