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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 50-797/S-024
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Pfizer, Inc.
`Attention: Michele Burtness
`Senior Manager, Worldwide Safety and Regulatory
`235 East 42nd Street
`New York, NY 10017
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`Dear Ms. Burtness:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated December 22, 2016
`received December 22, 2016, and your amendment, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Zmax (azithromycin extended release) for
`Oral Suspension, 2 g.
`
`This Prior Approval supplemental new drug application was submitted in response to an Agency
`supplement request letter dated November 3, 2016 to add acute generalized exanthematous
`pustulosis to Section 5.1 WARNINGS AND PRECAUTIONS and to subsection 6.2
`Postmarketing Experience in order to furnish adequate information for the safe and effective
`use of the product.
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`APPROVAL & LABELING
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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, 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 Standard for Content of Labeling Technical Qs and As at
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`Reference ID: 4076938
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`NDA 50797/S-024
`Page 2
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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 include labeling changes
`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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`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, Chief Project Manager, at (301) 796-1203.
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`Sincerely,
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`{See appended electronic signature page}
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`Dmitri Iarikov, MD, PhD
`Acting Deputy Director
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 4076938
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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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`DMITRI IARIKOV
`03/30/2017
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`Reference ID: 4076938
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