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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 202236/S-008
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`Food and Drug Administration
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` Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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` FULFILLMENT OF POSTMARKETING
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` REQUIREMENTS
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`Meda Pharmaceuticals, Inc.
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`265 Davidson Avenue
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`Somerset, NJ 08873-4120
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`Attention: Cindy Yayac
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`Senior Manager, Regulatory Affairs
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`Dear Ms. Yayac:
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`Please refer to your Supplemental New Drug Application (sNDA) dated August 22, 2014,
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`received August 22, 2014, submitted under section 505(b)(2) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Dymista (azelastine hydrochloride and fluticasone propionate) Nasal
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`Spray 137 mcg/50 mcg.
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`We acknowledge receipt of your amendments dated October 23, December 19, 2014, and
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`January 21, and February 6, 16, and 19, 2015.
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`This “Prior Approval” supplemental new drug application provides for the use of Dymista
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`(azelastine hydrochloride and fluticasone propionate) for the treatment of symptoms of seasonal
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`allergic rhinitis in children 6 through 11 years of age.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
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`patient package insert, Instruction for Use), with the addition of any labeling changes in pending
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`“Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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`Reference ID: 3705083
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` NDA 202236/S-008
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` Page 2
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` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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` The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
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` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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` should provide appropriate annotations, including supplement number(s) and annual report
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` date(s).
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`FULFILLMENT OF POSTMARKETING REQUIREMENTS
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`We have received your submission dated August 22, 2014, containing the final reports for the
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`following postmarketing requirements listed in the May 1, 2012, approval letter.
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`1888-1
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`Conduct a trial to evaluate the long-term safety of Dymista in children 4 to 11
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`years of age with seasonal allergic rhinitis or perennial allergic rhinitis.
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`Conduct a trial to evaluate the efficacy and safety of Dymista in children 4 to 11
`1888-2
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`years of age with seasonal allergic rhinitis.
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`We have reviewed your submission and conclude that the above requirements were fulfilled.
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`This completes all of your postmarketing requirements acknowledged in our May 1, 2012,
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`approval letter.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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`Food and Drug Administration
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`Reference ID: 3705083
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` NDA 202236/S-008
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` Page 3
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` Center for Drug Evaluation and Research
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` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
` Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`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
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Sadaf Nabavian, Regulatory Project Manager, at (301) 796-2777.
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`Sincerely,
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`{See appended electronic signature page}
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`Sally Seymour, MD
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`Deputy Director for Safety
`Division of Pulmonary, Allergy, and
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`Rheumatology Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Content of Labeling (PI, PPI, IFU)
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`Reference ID: 3705083
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`SALLY M SEYMOUR
`02/20/2015
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`Reference ID: 3705083
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