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FDA Requests Additional Information for Risperidone NDA as Adjunctive Treatment in Bipolar Disorder

TITUSVILLE, N.J., Feb. 10 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional information regarding the company's supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection. The sNDA, submitted in April 2008, sought approval for RISPERDAL(R) CONSTA(R) for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.

The Agency's complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies.

J&JPRD is currently evaluating the FDA's complete response letter and will work with the Agency to resolve any outstanding questions.

Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression), and affects 5.7 million, or 2.6 percent, of the American adult population in any given year.

Source: Johnson & Johnson Pharmaceutical Research & Development

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