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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 50-797/S-016
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`Pfizer, Inc.
`Attention: Anna Maria Gambino
`Manager, Worldwide Regulatory Strategy
`235 East 42nd Street
`New York, NY 10017-5755
`
`Dear Ms. Gambino:
`
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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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`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated February 8, 2012,
`received February 9, 2012, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Zmax (azithromycin extended release) for Oral Suspension, 2.0g.
`
`This supplemental application was submitted in response to an Agency supplemental request
`letter dated November 15, 2011 to add wording concerning QT prolongation to the WARNINGS
`AND PRECAUTIONS sections of the label.
`
`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text and with
`the minor editorial revisions listed below.
`
`
`
`
`In the HIGHLIGHTS section, under the recent major changes subsection, deletion of the
`following consistent with 21 CFR 201.57 (a)(5). These labeling changes were made in
`2010.
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`CONTRAINDICATIONS, Cholestatic jaundice/hepatic dysfunction (4.2) 10/2010
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`WARNINGS AND PRECAUTIONS, Hepatotoxicity (5.2) 10/2010.
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`Addition of the following:
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`WARNINGS AND PRECAUTIONS, QT prolongation (5.5) 03/2012
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`We note that your February 8, 2012, submission includes final printed labeling (FPL) for your
`package insert. We have not reviewed this FPL. You are responsible for assuring that the
`wording in this printed labeling is identical to that of the approved content of labeling in the
`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
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`
`Reference ID: 3095364
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`

`

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`
` NDA 50-797/S-016
`Page 2
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`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.
`
`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
`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 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
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Carmen DeBellas, Regulatory Project Manager, at (301) 796-
`1023.
`
`
`Sincerely,
`
`{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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`
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`ENCLOSURE:
`Content of Labeling
`
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`Reference ID: 3095364
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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/
`----------------------------------------------------
`
`SUMATHI NAMBIAR
`03/01/2012
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`Reference ID: 3095364
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`