US health care major Johnson & Johnson has submitted two supplemental New Drug Applications to the Food and Drug Administration requesting approval for Invega (paliperidone) tablets for the treatment of schizoaffective disorder.
The condition, which encompasses the symptoms of schizophrenia and a major mood disorder, is about one third as common as schizophrenia, for which paliperidone ER is an approved treatment.
Earlier this week, the company also submitted its response to the FDA's queries on the New Drug Application for paliperidone palmitate, which it received last year (Marketletter September 1, 2008). The investigational once-monthly atypical antipsychotic injection will be indicated for the acute and maintenance treatment of schizophrenia if approved. J&J hopes its paliperidone franchise will help replace revenues lost when its blockbuster antipsychotic Riserpdal (risperidone) lost patent protection last year.
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