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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-821/S-043
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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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` Pfizer, Inc.
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` Attention: Nadia D. Kirzecky
` Director, Worldwide Safety and Regulatory
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`235 East 42nd Street
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`New York, NY 10017
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`Dear Ms. Kirzecky:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 9, 2015,
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`received December 9, 2015, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Tyagcil (tigecycline) Injection.
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`This “Prior Approval” supplemental new drug application provides for revisions to several
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`sections of the labeling to be consistent with the Physicians Labeling Rule (PLR) and revisions
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`to the INDICATIONS AND USAGE Section, Community-Acquired Bacterial Pneumonia
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`subsection (1.3), OVERDOSAGE section (10), and the CLINICAL PHARMACOLOGY,
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`Section, Microbiology Subsection (12.4).
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`APPROVAL & LABELING
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`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 for the INDICATIONS and USAGE Section and the
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`Microbiology subsection (12.4) listed below and indicated in the enclosed labeling.
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`1. The qualifier (beta-lactamase-negative isolates) that is associated with H. influenzae be
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`removed from the indications and from the list of organisms in the Microbiology section.
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`2. One of the footnotes on anaerobic techniques (4) is missing after the word “method”.
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`This references CLSI M100.
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`3. In the Susceptible, Intermediate, Resistant definitions delete the “s” in the word
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`“concentrations”. This word is used in the definition for Susceptible and also Resistant.
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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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`of labeling must be identical to, except with the revisions listed and indicated, the enclosed
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`Reference ID: 3874843
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` NDA 21-821/S-043
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` Page 2
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` labeling text for the package insert with the addition of any labeling changes in pending
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` “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`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 via 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
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` [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes with the revisions
` listed and indicated above approved in this supplemental application, as well as annual reportable
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` changes, and annotate each change. To facilitate review of your submission, provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft Word
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` version. The marked-up copy should provide appropriate annotations, including supplement
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`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
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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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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3874843
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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
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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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
`01/19/2016
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`Reference ID: 3874843
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