Vagistat-1 exclusivity until February 2000 under consideration at FDA generics office.
This article was originally published in The Tan Sheet
Executive Summary
VAGISTAT-1 MARKET EXCLUSIVITY UNTIL FEBRUARY 2000 is under consideration at the FDA Office of Generic Drugs. A decision on whether the recently approved one-dose Rx-to-OTC switch vaginal yeast infection treatment should be awarded three years of marketing exclusivity is expected in April. Bristol-Myers Squibb's 6.5% tioconazole vaginal ointment was approved on Feb. 11 ("The Tan Sheet" Feb. 17, p. 1).
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