Executive Summary

OTC NASALCROM MARKET EXCLUSIVITY "FULL BASIS" FOR DECISION REQUESTED by the New York City firm Bass & Ullman on behalf on an unnamed client in a Sept. 9 letter to FDA. The agency granted three years of marketing exclusivity to the cromolyn sodium 4% OTC nasal solution product despite the Jan. 14 citizen petition filed by the law firm objecting to such an award. Bass & Ullman is seeking an "immediate ruling" on the petition "so that affected members of the public can be informed of the bases of FDA action, thereby enabling them to take further appropriate action, including judicial review, if that should be deemed necessary."