Bristol effort to overturn Upsher-Smith cholestyramine ANDA approval denied by D.C. federal court.
UPSHER CHOLESTYRAMINE ANDA: BRISTOL DENIED IN REQUEST TO SET ASIDE approval granted by FDA Feb. 22 for Upsher-Smith's Prevalite, the first generic of Bristol-Myers Squibb's Questran, in D.C. federal court on March 25. Bristol filed a motion for preliminary injunctive relief, requesting that the court set aside FDA's approval of Prevalite because the determination that the drug is bioequivalent to Questran was based solely on in vitro studies. Washington, D.C. federal court Judge Ricardo Urbina denied Bristol's preliminary request.
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