DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205641/S-002 SUPPLEMENT APPROVAL Merck Sharp and Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000, UG2C-26 North Wales, PA 19454-2505 Attention: Scott Hambaugh Director, Regulatory Liaison Dear Mr. Hambaugh: Please refer to your Supplemental New Drug Application (sNDA) dated March 13, 2015, received March 13, 2015, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Asmanex HFA (mometasone furoate) Inhalation Aerosol 100 mcg and 200 mcg. This “Changes Being Effected” supplemental new drug application proposes changes to the actuator and canister labels to identify the strengths of Asmanex HFA when the device is assembled. APPROVAL & LABELING We have completed our review of this supplemental application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon carton/container labeling. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed carton and 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 Carton and Container Labels for approved NDA 205641/S-002.” 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. Reference ID: 3779955 NDA 205641/S-002 Page 2 PROMOTIONAL MATERIALS You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with annotated references, and (3) the package insert(s) to: Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road Beltsville, MD 20705-1266 You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. 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 Jessica Lee, Regulatory Project Manager, at (301) 796-3769. Sincerely, {See appended electronic signature page} Badrul A. Chowdhury, MD, PhD Director Division of Pulmonary, Allergy, and Rheumatology Products Office of Drug Evaluation II Center for Drug Evaluation and Research ENCLOSURE(S): Carton and Container Labeling Reference ID: 3779955 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------BADRUL A CHOWDHURY 06/16/2015 Reference ID: 3779955