DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207946 NDA APPROVAL Janssen Pharmaceuticals, Inc. Attention: Beth Geter-Douglass, Ph.D. Associate Director, Global Regulatory Affairs 1125 Trenton-Harbourton Road P.O. Box 200 Titusville, NJ 08560 Dear Dr. Geter-Douglass: Please refer to your New Drug Application (NDA) dated and received November 18, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Invega Trinza (paliperidone palmitate) 273 mg, 410 mg, 546 mg, and 819 mg extended-release injectable suspension. We acknowledge receipt of your amendments dated December 18, 2014, December 18, 2014, December 22, 2014, January 5, 2015, January 21, 2015, January 27, 2015, February 2, 2015, February 6, 2015, February 13, 2015, February 20, 2015, February 27, 2015, March 20, 2015, March 23, 2015, March 25, 2015, March 25, 2015, March 27, 2015, April 1, 2015, April 10, 2015, April 17, 2015, May 4, 2015, and May 12, 2015. This new drug application provides for the use of Invega Trinza (paliperidone palmitate) extended-release injectable suspension for the treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months. We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text. WAIVER OF HIGHLIGHTS SECTION We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of prescribing information. This waiver applies to all future supplements containing revised labeling unless we notify you otherwise. WAIVER OF PREGNANCY, LABOR AND DELIVERY, AND NURSING MOTHERS SUBSECTIONS Reference ID: 3755541 NDA 207946 Page 2 We are waiving the current requirements of 21 CFR 201.56(d)(1) and 201.57(c)(9)(i) through (iii), regarding the content and format of labeling for subsections 8.1 Pregnancy, 8.2 Labor and Delivery, and 8.3 Nursing Mothers of prescribing information. Your approved labeling for subsections 8.1, 8.2, and 8.3 reflects the content and format requirements of the Pregnancy and Lactation Labeling Rule (79 FR 72063, December 4, 2014) which implements on June 30, 2015. CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must be identical to the enclosed labeling (text for the package insert, text for the patient package insert, Medication Guide). Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your May 12, 2015 email containing final printed carton and container labels. REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients unless this requirement is waived, deferred, or inapplicable. We are waiving the pediatric studies requirement for this application because necessary studies are impossible or highly impracticable in patients aged birth to 12 years of age, and this product does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients and is not likely to be used in a substantial number of pediatric patients in patients aged 13-17 years. PROMOTIONAL MATERIALS You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed materials in draft or mock-up form with annotated references, and the package insert to: Reference ID: 3755541 NDA 207946 Page 3 Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion 5901-B Ammendale Road Beltsville, MD 20705-1266 As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the package insert, at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Form FDA 2253 is available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf. Information and Instructions for completing the form can be found at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, please email Ann Sohn, Regulatory Project Manager, at ann.sohn@fda.hhs.gov. Sincerely, {See appended electronic signature page} Mitchell V. Mathis, M.D. CAPT USPHS Director Division of Psychiatry Products Office of Drug Evaluation I Center for Drug Evaluation and Research Enclosures: Content of Labeling Carton and Container Labeling Reference ID: 3755541 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------MITCHELL V Mathis 05/18/2015 Reference ID: 3755541