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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-572/S-061
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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-2CD48
`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 April 20, 2018,
`received April 20, 2018, and your amendment, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Cubicin (daptomycin for injection), 500 mg/vial and
`Cubicin RF (daptomycin for injection), 500 mg/vial.
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`This “Changes Being Effected” supplemental new drug application provides for revisions to the
`HIGHLIGHTS OF PRESCRIBING INFORMATION, ADVERSE REACTIONS (6)
`section, Post-Marketing Experience (6.2) subsection, CLINICAL PHARMACOLOGY (12)
`section, Microbiology (12.4) subsection, and the REFERENCES (15) section, of the package
`inserts and minor editorial revisions.
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`More specifically, additional information related to “thrombocytopenia” and “platelet count”
`have been added to the prescribing information, in addition to revisions to the susceptibility test
`interpretive criteria, per the December 2017 FDA Guidance for Industry: “Systemic Antibacterial
`and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs.”
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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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`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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`Reference ID: 4357458
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`NDA 21-572/S-061
`Page 2
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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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 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 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(S): Content of Labeling
` - Cubicin
` - Cubicin RF
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`Reference ID: 4357458
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`Sincerely,
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`{See appended electronic signature page}
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`
` Dmitri Iarikov, MD, PhD
` Deputy Director
` Division of Anti-Infective Products
` Office of Antimicrobial Products
` Center for Drug Evaluation and Research
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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/
`------------------------------------------------------------
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`DMITRI IARIKOV
`12/03/2018
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`Reference ID: 4357458
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