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

(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- 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 SUSTENN®A (paliperidone palmitate). The sNDA seeks to expand the product's label to include data showing that treatment with INVEGA SUSTENN®A is effective six months longer than commonly prescribed oral antipsychotics in people with schizophrenia. INVEGA SUSTENNA® was...