Schering-Plough's Claritin (loratadine)

Executive Summary

NDA for nonsedating antihistamine "appears to have progressed sufficiently so that FDA approval should be granted shortly," company predicted in Feb. 11 press release. The NDA for the once- a-day product for seasonal allergic rhinitis was submitted in October 1986. Schering bases the statement "on no official action by FDA, but rather on discussions held with, and information requested by, the agency," the company said. FDA said Feb. 12 that it "has issued no action letters regarding Claritin".