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Executive Summary

SYNTEX FEMSTAT (BUTOCONAZOLE NITRATE) REDUCED THERAPY TIME is being emphasized by the firm in an announcement of the product's approval. Femstat "is the first three-day cream for the treatment of vaginal yeast infections in non-pregnant patients. In pregnant patients, six-day treatment is recommended . . . In contrast, all other currently available cream therapies must be used for at least seven days," Syntex said in a recent press release. FDA approved Femstat (butoconazole 2% cream) as a 1C antifungal agent, a classification indicating that the drug is a new chemical entity representing little therapeutic gain. A suppository form containing 100 mg butoconazole was also cleared by the agency. The firm said that Femstat is highly effective in treating candidiasis, a common form of vaginitis that can cause itching, unusual discharge and pain during intercourse. Syntex stated that, "unlike suppositories and inserts, ]Femstat[ cream can be applied externally to treat symptoms such as itching and soreness. Femstat's low rate of absorption means it stays mainly on surface tissues at the application site, where most of the infecting fungi are." Syntex said it will begin marketing the new product during the first quarter, and that physicians can start prescribing Femstat in mid-February.

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