Friday, August 14, 2009

FDA: Saphris (Asenapine) Approval, Schizophrenia and Bipolar

From the FDA:

FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder

The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”

Read the full FDA press release

S-P corporate press release

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