Thompson Medical's Encare

Executive Summary

FDA told the firm in an April 13 reg letter that labeling of the vaginal contraceptive for protection against gonorrhea and other venereal disease makes Encare a new drug requiring an approved NDA for continued marketing. FDA said it is "not aware that this particular indication for use has ever been used for OTC vaginal contraceptive products marketed in the U.S. for a material time or to a material extent" or that the spermicides have been generally recognized among experts as safe and effective for such use.