Flibanserin HSDD Clinical Trial Results May Not Be Generalizable, Panel Says
Executive Summary
Safety and efficacy results from the clinical trial program for Boehringer Ingelheim's Girosa (flibanserin) may not be generalizable to the broad population of premenopausal women with hypoactive sexual desire disorder, members of the FDA's Reproductive Health Drugs Advisory Committee said June 18
You may also be interested in...
Flibanserin Fails To Improve Sexual Desire, FDA Advisory Committee Says
Boehringer Ingelheim unable to show sufficient efficacy for Girosa in hypoactive sexual desire disorder in women.
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