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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202236
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`Food and Drug Administration
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`Silver Spring MD 20993
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`NDA APPROVAL
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`Meda Pharmaceuticals, Inc.
`265 Davidson Avenue, Suite 300
`Somerset, NJ 08873-4120
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`Attention: Brenda Jadney, B.A.
` Associate Director, Regulatory Affairs
`
`Dear Ms. Jadney:
`
`
`Please refer to your New Drug Application (NDA) dated April 1, 2011, received April 1, 2011,
`submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for
`Dymista® (azelastine hydrochloride and fluticasone proprionate) Nasal Spray, 137 mcg/50mcg.
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`We acknowledge receipt of your amendments dated April 29, May 19, July 1, August 1 (2), and
`15, September 16 and 23, October 10, 12, 18, and 25, and December 7 and 16, 2011, and
`February 27, March 13, 23, 27, and 29 (2), and April 4, 12, 26 and 30 (2), 2012.
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`This new drug application provides for the use of Dymista Nasal Spray for the relief of
`symptoms of seasonal allergic rhinitis in patients 12 years of age and older who require treatment
`with both azelastine hydrochloride and fluticasone proprionate for symptomatic relief.
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`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.
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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
`patient package insert). Information on submitting SPL files using eLIST may be found in the
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`guidance for industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`
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`Reference ID: 3124523
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`

`

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`NDA 202236
`Page 2
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`The SPL will be accessible via publicly available labeling repositories.
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` CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the enclosed carton labels
`submitted on April 12, 2012, and immediate container labels submitted on April 26, 2012, 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 titled “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 202236.” Approval of this submission by FDA is not
`required before the labeling is used.
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`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.
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`EXPIRY DATING PERIOD
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`Your product has been approved for an expiry dating period of 24 months when stored
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`upright with the dust cap in place at controlled room temperature 20° - 25°C (68° - 77°F).
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`MARKET PACKAGE
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`Please submit one market package of the drug product when it is available to the following
`address:
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`
`Philantha Bowen
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`White Oak Building 22, Room: 3326
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`10903 New Hampshire Avenue
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`Silver Spring, Maryland
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`Use zip code 20903 if shipping via United States Postal Service (USPS).
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`Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL, FedEx).
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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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`Reference ID: 3124523
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`

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`NDA 202236
`Page 3
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`We are waiving the pediatric study requirement for ages 0 to < 2 years because necessary studies
`are impossible or highly impractical and the existence of seasonal allergic rhinitis in patients < 2
`years of age is uncertain.
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`We are also waiving the pediatric study requirement for ages 2 to < 4 years 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.
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`We are deferring submission of your pediatric studies for ages 4 through 11 years for this
`application because the product is ready for approval in adults and the pediatric studies have not
`been completed.
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`Your deferred pediatric studies required by section 505B(a) of the Federal Food, Drug, and
`Cosmetic Act are required postmarketing studies. The status of these postmarketing studies must
`be reported annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food,
`Drug, and Cosmetic Act. The required studies are listed below.
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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
`years of age with seasonal allergic rhinitis or perennial allergic rhinitis.
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`Final Protocol Submission: October 2012
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`Study Completion:
`February 2014
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`Final Report Submission:
`June 2014
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`Conduct a trial to evaluate the efficacy and safety of Dymista in children 4 to 11
`years of age with seasonal allergic rhinitis.
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`Final Protocol Submission: February 2013
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`Study Completion:
`December 2013
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`Final Report Submission:
`June 2014
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`Submit the protocol(s) to your IND 77363, with a cross-reference letter to this NDA.
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`Reports of these required pediatric postmarketing studies 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.
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`We note that you have fulfilled the pediatric study requirement for ages 12 to 17 years for this
`application.
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`1888-2
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`Reference ID: 3124523
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`

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`NDA 202236
`Page 4
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` PROMOTIONAL MATERIALS
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`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:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`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. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more
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`information about submission of promotional materials to the Office of Prescription Drug
`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
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Philantha Bowen, Regulatory Project Management Officer, at
`(301) 796-2466.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Badrul A. Chowdhury, M.D., Ph.D.
`Director
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`Division of Pulmonary, Allergy, and Rheumatology
`Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURES:
`Content of Labeling
`Carton and Container Labeling
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`Reference ID: 3124523
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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
`05/01/2012
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`Reference ID: 3124523
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