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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` Food and Drug Administration
` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` NDA 50797/S-021
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` Pfizer, Inc.
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` Attention: Michele Burtness
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` Senior Manager, Worldwide Safety and Regulatory
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` 235 East 42nd Street
` New York, NY 10017
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`Dear Ms. Burtness:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 30, 2015,
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`received December 30, 2015 and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Zmax (azithromycin extended release) for
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`Oral Suspension, 2 g.
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`This Prior Approval supplemental new drug application provides for the addition of information
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`regarding infantile hypertrophic pyloric stenosis to the WARNINGS AND PRECAUTIONS
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`section (5) of the label. In addition, the Microbiology subsection (12.4) has been updated.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`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
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`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
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling text for the package insert, with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`CM072392.pdf.
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`Reference ID: 4051680
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` NDA 50797/S-021
` Page 2
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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
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or
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`marked-up copy that shows all changes, as well as a clean Microsoft Word version. The
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`marked-up copy should provide appropriate annotations, including supplement number(s) and
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`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
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Carmen DeBellas, Chief, Project Management Staff, at
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`(301) 796-1203.
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`Sincerely,
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`{See appended electronic signature page}
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`Sumathi Nambiar, MD, MPH
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`Director
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`Division of Anti-Infective Products
`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`Content of Labeling
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`Reference ID: 4051680
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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
`02/09/2017
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`Reference ID: 4051680
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`(
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