Unmet Need Justifies Risks For Pediatric Use Of Antipsychotics, FDA Advisory Committee Says
This article was originally published in The Pink Sheet Daily
Panel’s votes on the safety of AstraZeneca’s Seroquel, Lilly’s Zyprexa and Pfizer’s Geodon to treat pediatric schizophrenia and bipolar disorder indicate that the severity of the conditions and need for additional treatments justify the known risks.
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FDA approves Lilly's Zyprexa and AstraZeneca's Seroquel for schizophrenia bipolar disease in the pediatric population.
The Highlights section of labeling for three atypical antipsychotic drugs with sNDAs for pediatric indications pending at FDA would emphasize the importance of correctly diagnosing bipolar disorder, Office of Drug Evaluation I Director Bob Temple said at a recent advisory committee meeting
Not only did three antipsychotic drugs receive FDA advisory committee endorsement June 10 for the acute treatment of schizophrenia and bipolar disorder in pediatric populations, but FDA said that if the sNDAs are approved, it will likely extrapolate pediatric maintenance claims from the adult data