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`Food and Drug Administration
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`Silver Spring MD 20993
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 207154
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`Reference ID: 3891973
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` NDA APPROVAL
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`Allergan, Inc.
`Attention: Jeremy McCumber, MS
`Director, Global Regulatory Affairs
`2525 Dupont Drive
`P.O. Box 19534
`Irvine, CA 92623-9534
`
`
`Dear Mr. McCumber:
`
`
`Please refer to your New Drug Application (NDA) dated and received April 28, 2015, and your
`amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for ACZONE (dapsone) Gel, 7.5%.
`
`This new drug application provides for the use of ACZONE (dapsone) Gel, 7.5% for the topical
`treatment of acne vulgaris in patients 12 years of age and 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.
`
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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
`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.
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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 immediate container labels that are identical to enclosed carton
`and immediate container labels, except with the revisions listed below, as soon as they are
`
`

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`Revise the carton and immediate container labels to reflect “Gel” (not “gel”) for
`consistency with the content of labeling.
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`NDA 207154
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`Page 2
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`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 207154.” Approval of this submission by FDA is not required
`before the labeling is used.
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`Marketing the product 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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`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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`We are waiving the pediatric study requirement for ages 0 to 8 years 11 months because
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`necessary studies are impossible or highly impracticable. This is because acne is extremely
`uncommon in pediatric patients below 9 years of age.
`
`We are deferring submission of your pediatric study for ages 9 to 11 years 11 months for this
`application because this product is ready for approval for use in adults and adolescents ages 12
`years and above and the pediatric study has not been completed.
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`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.
`
`
`3017-1
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`Conduct an open-label study to assess safety, pharmacokinetics, and treatment
`effect of ACZONE (dapsone) Gel, 7.5% in 100 pediatric subjects aged 9 years to
`11 years 11 months with acne vulgaris. Pharmacokinetic assessments will be done
`in at least 16 evaluable subjects under maximal use conditions.
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`Final Protocol Submission:
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`Study Completion:
`Final Report Submission:
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`06/2016
`03/2019
`11/2019
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`Submit the protocol(s) to your IND 054440, with a cross-reference letter to this NDA.
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`Reference ID: 3891973
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`

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`NDA 207154
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`Page 3
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` Report of this required pediatric postmarketing study must be submitted as a new drug
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`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 this study. When submitting
`the report, 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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`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,
`Medication Guide, and patient PI (as applicable) to:
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`OPDP Regulatory Project Manager
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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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`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 ).
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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. 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.
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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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`Reference ID: 3891973
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`

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`NDA 207154
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`Page 4
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`If you have any questions, call Strother D. Dixon, Senior Regulatory Project Manager, at (301)
`796-1015.
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`
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`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
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`
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`Enclosures:
`Content of Labeling
`Carton and Container Labeling
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`Reference ID: 3891973
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`

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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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`KENDALL A MARCUS
`02/24/2016
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`Reference ID: 3891973
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