Schering-Plough's Claritin (loratadine)
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".
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth