DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208079 NDA APPROVAL Promius Pharma, LLC Attention: Hari Nagaradona, PhD Vice President and Head of Regulatory Affairs 107 College Road East Princeton, NJ 08540 Dear Dr. Nagaradona: Please refer to your New Drug Application (NDA) dated and received April 6, 2015, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Sernivo™ (betamethasone dipropionate) Spray, 0.05%. This new drug application provides for the use of Sernivo™ (betamethasone dipropionate) Spray, 0.05% for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or 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. 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, text for the instructions for use). 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 Reference ID: 3883178 NDA 208079 Page 2 Submit final printed carton and immediate container labels that are identical to the enclosed carton and immediate container labels and carton and immediate container labels submitted on December 23, 2015, 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 Carton and Container Labels for approved NDA 208079.” Approval of this submission by FDA is not required before the labeling is used. Marketing the product with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug. ADVISORY COMMITTEE Your application for Sernivo (betamethasone dipropionate) Spray, 0.05% was not referred to an FDA advisory committee because betamethasone dipropionate has been marketed in different formulations for over 40 years, and there are no novel issues requiring advice from the committee. 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 11 years 11 months 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. Topical corticosteroid products are available for treating pediatric patients with psoriasis. We are deferring submission of your pediatric assessment for ages 12 years to 16 years 11 months for this application because this product is ready for approval for use in adults and the pediatric study has not been completed. Your deferred pediatric study required by section 505B(a) of the FDCA is a required postmarketing study. The status of this postmarketing study must be reported annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the FDCA. This required study is listed below. 3016-1 Conduct a study to evaluate safety and pharmacokinetics of Sernivo (betamethasone dipropionate) Spray, 0.05% versus Diprolene Lotion, 0.05% in Reference ID: 3883178 NDA 208079 Page 3 pediatric subjects 12 years to 16 years 11 months of age with moderate to severe plaque psoriasis. Assess potential hypothalamic-pituitary-adrenal (HPA) axis suppression and drug levels of Sernivo Spray, 0.05% and Diprolene Lotion, 0.05%. Study drugs will be applied twice daily under maximal use conditions for 15 or 29 days. Final Protocol Submission: 06/2015 (Completed) Study Completion: 03/2018 Final Report Submission: 07/2018 Report of this required pediatric postmarketing study 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. 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 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. Reference ID: 3883178 NDA 208079 Page 4 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 Dawn Williams, Regulatory Project Manager, at (301) 796-5376. Sincerely, {See appended electronic signature page} Kendall A. Marcus, MD Director Division of Dermatology and Dental Products Office of Drug Evaluation III Center for Drug Evaluation and Research Enclosures: Content of Labeling Carton and Container Labeling Reference ID: 3883178 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------KENDALL A MARCUS 02/05/2016 Reference ID: 3883178