J&J Replies to Complete Response for Invega NDA

Johnson & Johnson (J&J) has replied to the FDA’s complete response letter on a monthly injectable formulation of its atypical antipsychotic Invega. The agency had asked for additional data in a complete response letter last year. The drug, paliperidone palmitate, is a long-acting ester of Invega intended for acute and maintenance treatment of schizophrenia with less frequent doses. The drug is a metabolite of Risperdal (risperidone), another atypical antipsychotic drug.
Washington Drug Letter