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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-572/S-043
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`NDA 21-572/S-044
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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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`Cubist Pharmaceuticals, Inc.
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`Attention: Jennifer Liscouski
`Senior Manager, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Ms. Liscouski:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated April 8, 2013,
`received April 8, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for CUBICIN (daptomycin for injection) 500 mg/vial.
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`We acknowledge receipt of your amendment (S-043) dated September 23, 2013.
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`These “Changes Being Effected” supplemental new drug applications provide for the following:
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` S-043: Updates to Section 6.2, Post-Marketing Experience subsection of the package
`insert to include the additional adverse reactions “angioedema” and “drug rash with
`eosinophilia and systemic symptoms” (DRESS) under Immune System Disorders.
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` S-044: An updated telephone number in the HIGHLIGHTS, ADVERSE REACTIONS
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`section to allow for the reporting of suspected adverse reactions.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended, and they are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling 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
`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:
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Reference ID: 3411741
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`NDA 21-572/S-043
`NDA 21-572/S-044
`Page 2
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`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.
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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:
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`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 that includes labeling 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 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
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call J. Christopher Davi, MS, Senior, Regulatory Project Manager, at
`(301) 796-0702.
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`ENCLOSURE: Content of Labeling
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`Reference ID: 3411741
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`Sincerely,
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`{See appended electronic signature page}
`
` Katherine A. Laessig, MD
`Deputy Director
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`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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`KATHERINE A LAESSIG
`11/22/2013
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`Reference ID: 3411741
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