FDA’s Psychopharmacologic Drugs Advisory Committee
Will meet July 19 to consider Bristol-Myers' NDA (20-152) for nefazodone and preclinical toxicity data "relevant to the risk benefit assessment" of Janssen's Risperdal (risperidone), a June 25 Federal Register notice states. Risperdal, (NDA 20-272), a dopamine and serotonin blocker, received a unanimous approval recommendation from the committee on April 29 ("The Pink Sheet" May 3, p. 12). The committee will meet July 20 to consider Lilly's NDA (20-187) for Prozac (fluoxetine) for use in the treatment of obsessive compulsive disorder. Meetings will begin both days at 8:30 a.m. in conference rooms D and E at FDA's Parklawn Building in Rockville, Md.
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