St. Renatus LLC announces FDA approval of Kovanaze dental anesthetic nasal spray

The first dental anesthetic nasal spray, Kovanaze from St. Renatus LLC, has received FDA approval for use in dentistry.

Jul 12th, 2016
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The first dental anesthetic nasal spray, Kovanaze from St. Renatus LLC, has received FDA approval for use in dentistry.

St. Renatus LLC, a privately held company based in Fort Collins, Colorado, announced today that it received US Food and Drug Administration (FDA) approval on June 29, 2016, for its first product, Kovanaze, a dental anesthetic (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, CEO of St. Renatus.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal 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.

Learn more about Kovanaze and St. Renatus at st-renatus.com. For the full prescribing information for Kovanaze, see the package insert.

Source: St. Renatus press release, 12 July 2016


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