J&J Receives FDA Complete Response Letter for Invega Sustenna Label Change

Janssen Pharmaceuticals, Inc. reports that the US Food and Drug Administration (FDA) issued a Complete Response letter regarding the supplemental new drug application (sNDA) for the company’s 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 approved in more than 80 countries.

Source: Johnson & Johnson

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