FDA Advisory Panel To Consider Seroquel, Zyprexa And Geodon For Kids, Teens
Although it's been known for a few weeks that the FDA's psychopharmacology advisory committee would meet in early June to make recommendations to the FDA proper regarding approval of Seroquel, an atypical antipsychotic, for use in children and teens aged 13 to 17 with schizophrenia and those aged 10 to 17 with pediatric bipolar disorder, it wasn't clear if other drugs would be considered at the same time. Yesterday, news came out of the FDA that Zyprexa and Geodon were coming along for the ride as well. Pfizer is asking the FDA to approve Geodon for the "acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in patients 10 to 17 years old." Lilly is seeking FDA approval of Zyprexa for the "acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents."
Lovely.
The hearings are set for June 9 and 10 in Maryland.
Posted by Philip Dawdy at May 7, 2009 12:03 AM
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