Friday, August 14, 2009

Schering-Plough Gets FDA Approval for Saphris

Schering-Plough Corp.'s new drug for schizophrenia and bipolar disorder, Saphris, has been approved by the Food and Drug Administration.

The pill, taken twice a day, is the first mind-altering medication to get simultaneous approval for treating both conditions, but it will face significant competition in a crowded market.

For now, it is only specifically approved for short-term use for acute problems, such as when patients have a psychotic episode. However, the drug's label, or detailed package insert, recommends patients responding well to Saphris should continue on it.

Kenilworth, N.J.-based Schering-Plough has completed some studies and is finishing up others on the long-term safety and effectiveness of the drug, spokesman Robert Consalvo said Friday. The company plans to eventually seek official approval for ''maintenance treatment.''


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