Novalar Pharmaceuticals granted approval for first dental anesthesia reversal agent, phentolamine mesylate (OraVerse).
Novalar Pharmaceuticals has received word from the Food & Drug Administration that it may begin marketing phentolamine mesylate (OraVerse) for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local anesthetic agent. According to the manufacturer, the approval marks the first time a drug has been cleared for this indication. Phentolamine accelerates the return to normal sensation and function following restorative and periodontal maintenance procedures. The drug is not recommended for use in children under six years of age or weighing less than 15 kg. The company expects to launch the new product in late 2008.