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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 50-797/S-013
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` PF Prism C.V.
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` c/o Pfizer Manufacturing Holdings LLC
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` Attention: Shai Srulovich, RPh, PharmD
` Senior Manager, Worldwide Safety & Regulatory
`235 East 42nd Street
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`New York, NY 10017
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`Dear Dr. Srulovich:
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`Please refer to your Supplemental New Drug Application (sNDA) dated November 30, 2010,
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`received November 30, 2010, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Zmax (azithromycin extended release) for Oral Suspension.
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`We acknowledge receipt of your amendment dated August 13, 2013.
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`The August 13, 2013, submission constituted a complete response to our June 7, 2011, action
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`letter.
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`This “Prior Approval” supplemental new drug application proposes to update the Microbiology
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`subsection of the package insert.
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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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`We note that your August 13, 2013, submission includes final printed labeling (FPL) for your
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`package insert. We have not reviewed this FPL. You are responsible for assuring that the
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`wording in this printed labeling is identical to that of the approved content of labeling in the
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`structured product labeling (SPL) format.
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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
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`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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`Reference ID: 3389169
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` NDA 50-797/S-013
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` Page 2
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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
`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
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`“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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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that includes 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
`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 marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`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, Regulatory Project Manager, at (301) 796­
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`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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`Acting Director
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`Division of Anti-Infective Products
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`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: 3389169
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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
`10/11/2013
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`Reference ID: 3389169
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