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FDA Accepts Correvio's Resubmitted NDA for Brinavess

Increase font size  Decrease font size Date:2019-07-30   Views:448

Correvio Pharma announced the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult patients. The FDA assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application.

 
 
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