ARTICLE | Company News

Injectable paliperidone gets complete response letter

August 27, 2008 2:13 AM UTC

Johnson & Johnson (NYSE:JNJ) received a complete response letter from FDA for an NDA for paliperidone palmitate to treat schizophrenia and prevent recurrence of schizophrenia symptoms. The company said FDA requested additional data but did not ask for any further studies of the once-monthly intramuscular injection, which uses NanoCrystal formulation technology from Elan (NYSE:ELN). J&J markets a once-daily tablet formulation of paliperidone as Invega. Paliperidone is a metabolite of J&J's Risperdal risperidone. ...