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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Feds seek to punish drug companies for off-label marketing

U.S. District Court Judge Patti Saris had seen cases like this before, and she was fed up.

Another pharmaceutical company was in her court, waiting to be slapped with a multi-million-dollar fine for marketing its drugs for uses that had not been approved by the federal Food & Drug Administration.

“You can't thumb your nose at the FDA,” Saris said. She sentenced Schering Sales Corp. and its parent company, Schering-Plough Corp. earlier this year to pay $435 million to settle allegations it lied to the government about drug prices and illegally promoted the drugs Temodar and Intron A for the treatment of cancers for which they were not approved.

READ MORE @ Associated Press