GLAXO WELLCOME FLOLAN REDUCES MORTALITY IN PRIMARY PULMONARY HYPERTENSION; INDICATED FOR CHRONIC USE WITH INDWELLING CENTRAL VENOUS CATHETER
Executive Summary
Glaxo Wellcome's Flolan (epoprostenol for injection) reduces mortality in patients who develop primary pulmonary hypertension, an orphan condition, according to data contained in the company's NDA, approved by FDA Sept. 20. Flolan is indicated for treatment of primary pulmonary hypertension in New York Heart Association Class III and Class IV patients, the first therapy approved for the condition. Flolan was designated "1P" by the agency, denoting a new molecular entity given priority review.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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