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Cleviprex FDA Approval History

FDA Approved: Yes (First approved August 1, 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 timeline for Cleviprex

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

Further information

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