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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-572/S-058
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp.
`Attention: Sandra Lynn Wood, PhD
`Director, Global Regulatory Affairs
`351 North Sumneytown Pike
`P.O. Box 1000, Mailstop UG-2C48
`North Wales, PA 19454-2505
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`Dear Dr. Wood:
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`Please refer to your Supplemental New Drug Application (sNDA) dated March 28, 2017
`received March 28, 2017, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Cubicin RF (daptomycin for injection), 500 mg/vial.
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`This Prior Approval supplemental new drug application provides for updates to the product
`labeling to align the prescribing information with the labeling changes approved on March 29,
`2017, for Cubicin. Additionally, this supplement provides for revisions to the carton and
`container labeling to help distinguish Cubicin RF from Cubicin.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application and it is approved, effective on
`the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`WAIVER OF HIGHLIGHTS SECTION
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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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: 4077171
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`NDA 21-572/S-058
`Page 2
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`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:
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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 include 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, 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-058.” Approval
`of this submission by FDA is not required before the labeling is used.
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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: 4077171
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`NDA 21-572/S-058
`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
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Content of Labeling
`Carton and Container Labeling
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`ENCLOSURES:
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`Reference ID: 4077171
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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
`03/29/2017
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`Reference ID: 4077171
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