Supplemental new drug applications for Invega Sustenna (paliperidone palmitate) submitted to the U.S. FDA for the treatment of schizoaffective disorder

FDA

Janssen Pharmaceuticals, Inc., today announced the submission of supplemental New Drug Applications (sNDAs) for once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to the U.S. Food and Drug Administration (FDA) for approval to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Without treatment, the symptoms of schizoaffective disorder are complex and disabling. Currently, treatment options approved to manage the symptoms of depression, mania and psychosis associated with the condition are limited. 

Invega Sustenna is the first long-acting injection to be studied for the treatment of schizoaffective disorder and – if approved by the FDA – will be the only long-acting injection indicated to treat this condition. Invega Sustenna was approved by the FDA in July 2009 as the first once-monthly atypical long-acting medication to treat schizophrenia.

For more details, go to: http://www.janssenpharmaceuticalsinc.com/assets/IS%20SCA%20sNDA%20Press%20Release%20-%20Final.pdf

Michael Wonder

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Michael Wonder

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