`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
` NDA 21-572/S-040
`
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Cubist Pharmaceuticals, Inc.
`Attention: Jennifer A. Liscouski
`Senior Manager, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
`
`
`Dear Ms. Liscouski:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated October 7, 2011,
`received October 7, 2011, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for CUBICIN (daptomycin for injection).
`
`We also acknowledge receipt of your amendments dated June 4 and 28, and September 27, 2012.
`
`This “Prior Approval” supplemental new drug application provides for revisions to the “13.2
`Animal Toxicology” and/or Pharmacology section of the product labeling. Specifically, a new
`subsection entitled “Juvenile Animals” has been added to describe skeletal muscle and nerve
`effects in 7-week old juvenile dogs following 28 days of once-daily daptomycin administration.
`
`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.
`
`CONTENT OF LABELING
`
`
`
`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.
`
`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
`CM072392.pdf.
`
`
`
`
`Reference ID: 3202029
`
`
`
`
`
` NDA 21-572/S-040
`Page 2
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`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).
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call J. Christopher Davi, MS, Senior Regulatory Project Manager, at
`(301) 796-0702.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Katherine A. Laessig, MD
`
`Deputy Director
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE: Content of Labeling
`
`
`
`Reference ID: 3202029
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`KATHERINE A LAESSIG
`10/11/2012
`
`Reference ID: 3202029
`
`