DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207960 NDA APPROVAL Pfizer Inc. Attention: Lisha Cole Director, Worldwide Safety and Regulatory 235 East 42nd Street New York, NY 10017 Dear Ms. Cole: Please refer to your New Drug Application (NDA) dated February 4, 2015, received February 4, 2015, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for QuilliChew ER (methylphenidate hydrochloride) extendedrelease chewable tablets 20 mg, 30 mg, and 40 mg. This new drug application provides for the use of QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablets for Attention Deficit Hyperactivity Disorder (ADHD). 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. 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 and 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. Reference ID: 3856248 NDA 207960 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your November 11, 2015, submission 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 study requirement for ages 0 to 4 years because the product does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in this age group and is not likely to be used in a substantial number of pediatric patients in this group for the following reasons:  There are no validated diagnostic criteria and assessment measures for diagnosing ADHD in children 0 to 4 years of age;  Assessment measures for determining treatment effect in children 0 to 4 years of age are not well defined;  Non-medication interventions are preferred treatment for behavioral disorders such as ADHD in very young children (e.g., 0 to 4 years of age). Therefore, the use of medication to treat ADHD in children 0 to 4 years of age is generally not recommended, and studies in this age group are a challenge with regard to patient safety and study validity. We are deferring submission of your pediatric studies for patients ages 4 to 5 years for this application because this product is ready for approval for use in adults and pediatric patients ages 6 years and older, and the studies in patients ages 4 to 5 years have not been completed. Your deferred pediatric studies required by section 505B(a) of the FDCA are required postmarketing studies. The status of these postmarketing studies must be reported annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the FDCA. These required studies are listed below. 3009-1 Conduct a Pharmacokinetic study in Attention Deficit Hyperactivity Disorder (ADHD) patients aged 4 to 5 years old. Final Protocol Submission: Study Completion: Final Report Submission: Reference ID: 3856248 09/2016 12/2019 09/2020 NDA 207960 Page 3 3009-2 Conduct a 6-week, double-blind, placebo-controlled, randomized, parallel-group safety and efficacy study in children with Attention Deficit Hyperactivity Disorder (ADHD) 4 to 5 years of age using methylphenidate ER formulation (QuilliChew ER) Final Protocol Submission: Study Completion: Final Report Submission: 3009-3 09/2016 12/2019 09/2020 Conduct a 6-month, open-label extension study to obtain additional information on safety and tolerability of methylphenidate ER formulation (QuilliChew ER) in children 4 to 5 years of age with Attention Deficit Hyperactivity Disorder (ADHD) Final Protocol Submission: Study Completion: Final Report Submission: 09/2016 06/2020 03/2021 Submit the protocols to your IND 111020, with a cross-reference letter to this NDA. Reports of these required pediatric postmarketing studies must be submitted as a new drug application (NDA) or as a supplement to your approved NDA with the proposed labeling changes you believe are warranted based on the data derived from these studies. When submitting the reports, please clearly mark your submission "SUBMISSION OF REQUIRED PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of the submission. This product is appropriately labeled for use in ages 6 to 17 years for this indication. Therefore, no additional studies are needed in this pediatric group. 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, Medication Guide, and patient PI (as applicable) to: OPDP Regulatory Project Manager Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion 5901-B Ammendale Road Beltsville, MD 20705-1266 Alternatively, you may submit a request for advisory comments electronically in eCTD format. For more information about submitting promotional materials in eCTD format, see the draft Reference ID: 3856248 NDA 207960 Page 4 Guidance for Industry (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM443702.pdf ). 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, call Hiren Patel, Regulatory Project Manager, at (301) 796-2087. Sincerely, {See appended electronic signature page} Mitchell V. Mathis, M.D. Director Division of Psychiatry Products Office of Drug Evaluation I Center for Drug Evaluation and Research Enclosure(s): Content of Labeling Carton and Container Labeling Reference ID: 3856248 --------------------------------------------------------------------------------------------------------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 12/04/2015 Reference ID: 3856248