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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-572/S-038
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Cubist Pharmaceuticals, Inc.
`Attention: Jennifer A. 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 Application (sNDA) dated June 28, 2011, received,
`June 30, 2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Cubicin (daptomycin for injection).
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`This “Prior Approval” supplemental new drug application provides for revisions to Section 12.4
`of the labeling text, under “Susceptibility Testing Methods, Quality Control” in Table 10. The
`broth dilution minimum inhibitory concentration (MIC) range for Staphylococcus aureus (ATCC
`29213) has been changed from 0.25-1 µg/mL to 0.12-1 µg/mL.
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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 revision listed below:
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`• Please update reference #2 to the most recent version of this document with the next printing.
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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. Content
`of labeling must be identical to the enclosed labeling 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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`CM072392.pdf.
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`Reference ID: 3023692
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` NDA 21-572/S-038
`Page 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 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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`Sincerely,
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`{See appended electronic signature page}
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`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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`ENCLOSURE: Content of Labeling
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`Reference ID: 3023692
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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
`10/03/2011
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`Reference ID: 3023692
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