China Sky One Medical receives SFDA approval for producing Ciclopirox Olamine Vaginal Suppositories

Jul 23 2010

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today announced that the Company has obtained approval from the State Food and Drug Administration (SFDA) in China for the production of Ciclopirox Olamine Vaginal Suppositories. The document number for this drug is H20103320.

Ciclopirox Olamine Vaginal Suppositories were developed by CSKI's internal R&D team based on registration standards of similar imported drugs. The drug's main ingredient, Ciclopirox Olamine, is a synthetic broad-spectrum antibacterial that has been proven effective in clinical studies for treatment of fungal vaginal infections (candida albicans vaginitis) and fungal vaginal inflammation (colpits mycotica). It can resist or restrain most pathogenic streptomyces, including skin fungus and candida albicans as well as many kinds of nonpathogenic streptomyces, gram negative bacilli and gram positive bacilli. The drug is a good treatment option for partial infection as it is minimally absorbed by the skin.

"We greatly appreciate the dedicated efforts of our R&D and sales teams to bring new drugs like Ciclopirox Olamine Vaginal Suppositories to market," said Mr. Yan-Qing Liu, Chairman and CEO of China Sky One Medical. "We expect to launch this product in early 2011 and plan on gaining share in this large market by leveraging our extensive distribution network and strong OTC pharmaceutical sales force."