SUPPLEMENT APPROVAL
`
`NDA 021821/S-049
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`
`PF Prism CV
`c/o Pfizer Inc.
`Attention: Nestor Duci, MBA
`
`Senior Manager, Pfizer Global Regulatory Affairs
`
`445 Eastern Point Road,
`Groton, CT 06340
`
`
`Dear Mr. Duci:
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`Please refer to your supplemental new drug application (sNDA) dated January 13,
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`2020, received January 13, 2020, submitted under section 505(b)of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for Tygacil (tigecycline) for Injection.
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`This Prior Approval supplemental new drug application provides for proposed safety
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`related updates to the following sections of the US Prescribing Information:
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`Section 2 DOSAGE AND ADMINISTRATION and Section 5 WARNINGS AND
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`PRECAUTIONS: Recommendation for monitoring of blood coagulation
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`parameters, including blood fibrinogen
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`Section 6 ADVERSE REACTIONS: Addition of “hypofibrinogenemia” as a
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`postmarketing adverse reaction
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`In addition, Section 7 DRUG INTERACTIONS, was updated with the description of a
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`drug interaction regarding concomitant use of Tygacil with calcineurin inhibitors.
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`Minor editorial revisions were made throughout the labeling.
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`APPROVAL & LABELING
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`
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`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling.
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`Reference ID: 4629744
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`

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`NDA 021821/S-049
`Page 2
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (Prescribing
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`Information) with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the
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`enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.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
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`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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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`Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(s).
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`If you have any questions, call Christopher L. Smith, PharmD, MPH, Regulatory Project
`Manager at (301) 796-4851.
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`Dmitri Iarikov, MD, PhD
`Deputy Director
`Division of Anti-Infectives
`Office of Infectious Diseases
`
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
` Prescribing Information
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4629744
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`

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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`DMITRI IARIKOV
`06/23/2020 01:03:37 PM
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`Reference ID: 4629744
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`(
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