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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-572/S-046
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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
`Director, 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 May 28, 2014, received
`May 28, 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 acknowledge receipt of your amendments dated August 14 and November 21, 2014. The
`changes to the carton and container labeling proposed in the August 14, 2014, amendment were
`not reviewed as part of this supplement and should be submitted as a new CMC supplement.
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`This “Prior Approval” supplemental new drug application provides for revisions to the
`HIGHLIGHTS OF PRESCRIBING INFORMATION, WARNINGSAND PRECAUTIONS
`sections and the Pediatric Use subsection regarding the potential for nervous system and
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` muscular system effects in pediatric patients below 12 months of age. In addition, the Nursing
`Mothers and the Animal Toxicology and/or Pharmacology subsections of the package insert
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` were revised based on the results of a 28-day intravenous neonatal dog study.
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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
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`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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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Reference ID: 3664681
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`NDA 21-572/S-046
`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/Guida
`nces/UCM072392.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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`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 Office of Antimicrobial Product
`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling
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`Reference ID: 3664681
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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
`11/26/2014
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`Reference ID: 3664681
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