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HORSHAM, Pa. — The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.
Topaz is seeking approval for ivermectin topical cream, for treating head lice in children and adults.
“This filing represents the transition of the company from the development phase as we are now preparing to commercialize our lead product candidate,” Topaz president and CEO Robert Radie said. “Current treatment options are limited by one or more of safety, efficacy and convenience issues. We believe there is an unmet need to provide a new option for the more than 6 million people, mostly school-aged children, who are impacted by lice each year in the United States.”