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U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® (Johnson & Johnson)

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(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding the supplemental new drug application (sNDA) for once-monthly long-acting antipsychotic INVEGA SUSTENNA® (paliperidone palmitate). The sNDA seeks to expand the product's label to include data showing that treatment with INVEGA SUSTENNA® is effective six months longer than commonly prescribed oral antipsychotics in people with schizophrenia. INVEGA SUSTENNA® was approved by the FDA in July 2009 as the first once-monthly atypical long-acting injectable antipsychotic to treat schizophrenia and is now...

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