Novalar Obtains FDA Approval for OraVerse

Novalar Pharmaceuticals has announced that the FDA has granted marketing approval for OraVerse, which is indicated for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic.

Novalar is establishing a specialty direct sales force to launch OraVerse in late 2008. Novalar’s sales force will focus on general and pediatric dentists for use in patients over six years of age.

OraVerse’s approval for use in adults and children is based on data from several clinical studies, including two Phase III studies in adults and adolescents age 12 and older and a Phase II pediatric study.

Donna Janson, president and CEO of Novalar, said: “This first-in-class therapeutic will provide dental professionals with a novel solution to enhance the overall experience for their patients.”