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Anesthetic nasal spray for use in dentistry.

St. Renatus, LLC, a privately held company based in Fort Collins, Colorado, has announced it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for KOVANAZE[TM] (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.

The product is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic, but without the needle. It is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

According top UPenn News, the spray was deemed safe and effective in a Phase 3 clinical trial led by University of Pennsylvania School of Dental Medicine researchers. The results of the study were published in the April 2016 Journal of the American Dental Association.

Source: PR Newswire and

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Title Annotation:HEALTH
Date:Nov 1, 2016
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