LMWH hematoma warning need not be extended to other anticoagulants, FDA committee agrees.
Executive Summary
LMWH HEMATOMA WARNING NEED NOT BE EXTENDED TO OTHER ANTICOAGULANTS, FDA's Anesthetic & Life Support Drugs Advisory Committee agreed at a meeting Feb. 5. The committee voted 5-3 against extending a class boxed warning for low molecular weight heparin products concerning the incidence of spinal hematoma to the labeling of other anticoagulant products such as heparin and DuPont Merck's Coumadin (warfarin).
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
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: