FORT COLLINS, Colo., July 12, 2016 /PRNewswire/ — St. Renatus, LLC, a privately held company based in Fort Collins, Colorado, is pleased to announce it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, Kovanaze (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.
“For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia,” said Steve Merrick, St. Renatus’ CEO.
Kovanaze 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.
Kovanaze 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.
About St. Renatus
St. Renatus, LLC was founded to develop a revolutionary innovation—the world’s first-known dental anesthetic administered through the nasal cavity, designed for use in procedures involving most of the upper teeth, with a goal of gaining FDA approval to commercialize and distribute. The company’s name comes from the patron saint of anesthesia and has Latin roots meaning new beginning.
Learn more about St. Renatus by visiting www.st-renatus.com. Customer support line for Kovanaze: 1-800-770-9400.
SOURCE St. Renatus, LLC
Posted: July 2016
Source: FDA New Drug Approvals