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Novalar Receives FDA Approval for OraVerse(TM)
Date:5/12/2008

First approved dental anesthetic reversal agent

SAN DIEGO, May 12 /PRNewswire/ -- Novalar Pharmaceuticals, Inc., a dental specialty pharmaceutical company, announced today that the United States Food and Drug Administration (FDA) has granted marketing approval for OraVerse(TM) (phentolamine mesylate). OraVerse is the first pharmaceutical agent 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.

"The approval of OraVerse is the result of the outstanding efforts of our development team, our strong collaboration with the FDA and our focus and commitment to realizing the vision of our founder, Dr. Eckard Weber. This first-in-class therapeutic will provide dental professionals with a novel solution to enhance the overall experience for their patients," stated Donna Janson, President and Chief Executive Officer of Novalar.

Novalar plans to launch OraVerse at this year's American Dental Association (ADA) Annual Session being held in San Antonio, Texas from October 16-20, 2008. Novalar's sales force will focus on general and pediatric dentists for use in patients over six years of age.

Over 300 million cartridges of local dental anesthetic are sold each year in the U.S. alone. Although widely used, it frequently results in unnecessary and lingering soft tissue anesthesia and associated functional deficits. Novalar's market research with both patients and dentists has indicated strong interest in a product that will reduce the time to normal sensation and function following local dental anesthesia.

OraVerse's approval for use in adults and children is based on data from several clinical studies, including two Phase 3 studies in adults and adolescents age 12 and older and a Phase 2 pediatric study. The two Phase 3 studies were conducted in 18 centers across
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SOURCE Novalar Pharmaceuticals, Inc.
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