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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-572/S-048
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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, LLC
`Attention: Karen R. Terry, RAC
`Manager, Global Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Ms. Terry:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 3, 2014,
`received December 3, 2014, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Cubicin (daptomycin for injection) Intravenous, 500 mg/vial.
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`We also acknowledge receipt of your amendments dated January 30 and March 27, 2015.
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`This “Prior Approval” supplemental new drug application provides for revisions to the carton
`and container labeling to facilitate packaging consistency across your product lines.
`Additionally, this supplement provides for editorial revisions to the HIGHLIGHTS section.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended and 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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` Standard language relating to use of systemic antibacterial drug products (21 CFR
`201.24) should be moved in HIGHLIGHTS from beneath the Initial US approval date to
`the end of the INDICATIONS AND USAGE section.
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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:
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Reference ID: 3800804
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`NDA 21-572/S-048
`Page 2
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`Content of labeling must be identical to the enclosed labeling (which includes the above
`referenced revision), 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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` CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels submitted on January 30, 2015, as soon as they are
`available, but no more than 30 days after they are printed. Please submit these labels
`electronically according to the guidance for industry Providing Regulatory Submissions in
`Electronic Format – Human Pharmaceutical Product Applications and Related Submissions
`Using the eCTD Specifications (June 2008). Alternatively, you may submit 12 paper copies,
`with 6 of the copies individually mounted on heavy-weight paper or similar material. For
`administrative purposes, designate this submission “Final Printed Carton and Container
`Labels for approved NDA 21-572/S-048.” Approval of this submission by FDA is not required
`before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
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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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`Reference ID: 3800804
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`NDA 21-572/S-048
`Page 3
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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
`Director
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`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURES: Content of Labeling
`Carton and Container Labeling
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`Reference ID: 3800804
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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
`08/03/2015
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`Reference ID: 3800804
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