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.