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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 50-797/S-010
`NDA 50-797/S-012
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`NDA 50-797/S-014
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`S-010 dated July 30, 2009 received July 30, 2009
`S-012 dated July 21, 2010 received July 21, 2010
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`S-014 dated December 23, 2010 received December 23, 2010
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`
`Pfizer Global Research and Development
`Attention: Priso E. Epale
`Regulatory Manager, Worldwide Regulatory Strategy
`235 East 42nd Street 685/18/15
`New York, NY 10017
`
`Dear Mr. Epale:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Zmax (azithromycin extended
`release) for Oral Suspension, 2 g;
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`We acknowledge receipt of your amendments dated April 28, 2011 and May 24, 2011.
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`The April 28, 2011 and May 24, 2011, submissions constituted a complete response to our
`February 3, 2011, action letter.
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`Supplemental application S-010: “Changes Being Effected” supplemental new drug application
`provides for artwork combination from pediatric and adult packaging into unified packaging.
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`Supplemental application S-012: “Prior Approval” supplemental new drug application provides
`for the addition of pyloric stenosis to the ADVERSE REACTIONS section, Postmarketing
`Experience subsection.
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`Supplemental application S-014: “Prior Approval” supplemental new drug application provides
`for changes to the CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS
`sections of the labeling.
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`We have completed our review of these supplemental applications as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon package insert for supplemental applications 50-797/S-012 and S-014 and carton and
`container labels for supplemental application 50-797/S-010.
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`Reference ID: 2957280
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`NDA 50-797/S-010
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` NDA 50-797/S-012
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` NDA 50-797/S-014
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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 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
`titled “SPL Stantard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformatin/Guidance/UC
`M072392.pdf.
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`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 April 28, 2011, submission containing final printed carton and container
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`labels.
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`Reference ID: 2957280
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`NDA 50-797/S-010
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` NDA 50-797/S-012
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` NDA 50-797/S-014
` PROMOTIONAL MATERIALS
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`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:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`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/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Division of Drug Marketing, Advertising, and Communications
`(DDMAC), 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 Carmen DeBellas, Regulatory Project Manager, at (301) 796-
`1203.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Sumathi Nambiar, MD, MPH
`Deputy Director for Safety
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
`Carton and Container label
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`Reference ID: 2957280
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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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`SUMATHI NAMBIAR
`06/07/2011
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`Reference ID: 2957280
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