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Schering-Plough says FDA wants more Saphris data
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KENILWORTH, N.J. - The Food and Drug Administration wants to see more data on Schering-Plough Corp.'s schizophrenia treatment candidate Saphris, the drug maker said Wednesday, but the agency did not ask for new clinical trials.
Schering-Plough said the FDA asked for more details from trials of Saphris, and also suggested labeling for the drug. If the agency had asked for new clinical testing, the drug's approval could have been delayed by months or more than a year.
Schering-Plough did not specify what kind of data the FDA is seeking.
The company is developing Saphris, or asenapine, as a treatment for schizophrenia and bipolar mania in adults.
Schering-Plough said it will respond to the FDA's request during the first quarter.
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