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