FDA Approves OraVerse for Pediatric Dental Patients 3 Years and Older

Posted on June 16, 2016

Lancaster, Pennsylvania, USA – May 30, 2016 – Septodont announced that the United States Food and Drug Administration (FDA) has approved the change of the minimum age for OraVerse (Phentolamine Mesylate) from 6 years old to 3 years old.  The approval came as the result of a Phase IV, Multicenter, Randomized, Double-Blind, Controlled Study for the safety and efficacy of OraVerse in Pediatric Patients ages 3 – 5. 

OraVerse (Phentolamine Mesylate) is the first and only product to rapidly reverse the lingering numbness of the lip and tongue from local dental anesthetic. OraVerse is administered by the dentist immediately following routine procedures such as a filling or crown prep. Busy people who need to return to their jobs, kids who tend to chew their numb lips and cheeks, and diabetics who need to eat following a procedure are the types of individuals who can benefit greatly from OraVerse.

OraVerse is manufactured by Septodont and is available for purchase through a dental dealer.Septodont is a dental pharmaceutical company that specializes in innovative, safe and effective solutions for dentistry worldwide.

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