SCHERING PLOUGH CP, SGP
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Federal health regulators said Tuesday an experimental psychiatric drug from Schering-Plough Corp. appears to be a safe and effective treatment for patients with schizophrenia and bipolar disorder. In briefing documents posted online, FDA's director of psychiatry products Thomas Laughren said "we generally are in agreement that the sponsor has provided adequate support to suggest effectiveness.
" Laughren also said the drug appears about as safe as other drugs in the class, known as atypical antipsychotics. He added, however, that FDA has not reached a final conclusion on the drug. A panel of outside psychiatric experts will vote Thursday on whether the Food and Drug Administration should approve Schering's Saphris. The agency is not required to follow the group's advice, though it usually does.
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