DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207768 NDA APPROVAL Tris Pharma, Inc. 2033 Route 130, Suite D Monmouth Junction, New Jersey, 08852 Attention: Norma J. Cappetti Vice President, Regulatory Affairs Dear Ms. Cappetti: Please refer to your New Drug Application (NDA) dated June 27, 2014, received June 30, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Tuzistra XR (Codeine Polistirex and Chlorpheniramine Polistirex) Extended Release Oral Suspension, 14.7 mg of codeine and 2.8 mg chlorpheniramine per 5 mL. We acknowledge receipt of your amendments dated July 9, August 13, October 2, and 24, 2014, and February 10 and 26, March 18, 20, and 26, and April 9, 20, 22, 24, 29 (3), and 30 (2), 2015. This new drug application provides for the use of Tuzistra XR (Codeine Polistirex and Chlorpheniramine Polistirex) Extended Release Oral Suspension for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. 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. EXPIRATION DATING PERIOD A 24 month expiry period is granted for the drug product stored under the recommended roomtemperature storage conditions (20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). 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. Reference ID: 3744690 NDA 207768 Page 2 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). 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. IMMEDIATE CONTAINER LABELS Submit final printed immediate container labels that are identical to the: enclosed immediate container labels, as soon as they are available, but no more than 30 days after they are printed. Please submit these labels electronically according to the guidance for industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (June 2008). Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or similar material. For administrative purposes, designate this submission “Final Printed Container Labels for approved NDA 207768.” Approval of this submission by FDA is not required before the labeling is used. Marketing the product(s) with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug. 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. Because none of these criteria apply to your application, you are exempt from this requirement. Reference ID: 3744690 NDA 207768 Page 3 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: 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, call Sadaf Nabavian, Senior Regulatory Project Manager, at (301) 796-2777. Sincerely, {See appended electronic signature page} Lydia Gilbert-McClain, M.D. Deputy Director Division of Pulmonary, Allergy, and Rheumatology Products Office of Drug Evaluation II Center of Drug Evaluation and Research Enclosures: Content of Labeling Container Labeling Reference ID: 3744690 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------LYDIA I GILBERT MCCLAIN 04/30/2015 Reference ID: 3744690