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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 202236/S-001
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Meda Pharmaceuticals, Inc.
`265 Davidson Avenue, Suite 300
`Somerset, NJ 08873-4120
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`Attention: Brenda Jadney, BA
` Associate Director, Regulatory Affairs
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`Dear Ms. Jadney:
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`Please refer to your Supplemental New Drug Application (sNDA) dated May 30, 2012, received
`May 30, 2012, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137
`µg/50 µg.
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`We acknowledge receipt of your amendments dated July 30 and August 9, 2012.
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`This “Changes Being Effected” supplemental new drug application provides for minor editorial
`changes to the Highlights, Table of Contents, Carton and Container labels, and the Full
`Prescribing Information.
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`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 labeling
`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
`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
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`patient package insert) with the addition of any labeling changes in pending “Changes Being
`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
`labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`Reference ID: 3173070
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`NDA 202236/S-001
`Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`The SPL will be accessible from publicly available labeling repositories.
`Also within 14 days, amend all pending supplemental applications for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, 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 annotate each change. To
`facilitate review of your submission, provide a highlighted or marked-up copy that shows all
`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your August 9, 2012, submission containing final printed carton and container
`labels.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`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.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`Reference ID: 3173070
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`NDA 202236/S-001
`Page 3
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`If you have any questions, call Philantha Bowen, Senior Regulatory Project Management
`Officer, at (301) 796-2466.
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`Sincerely,
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`{See appended electronic signature page}
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`Badrul A. Chowdhury, MD, Ph.D.
`Director
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`Division of Pulmonary, Allergy, and Rheumatology
`Products
`Office of Drug Evaluation
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
`Carton and Container Labeling
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`Reference ID: 3173070
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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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`BADRUL A CHOWDHURY
`08/10/2012
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`Reference ID: 3173070
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