`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 21-572/S-050
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`Cubist Pharmaceuticals, LLC
`A subsidiary of Merck & Co., Inc.
`Attention: Karen R. Terry, RAC
`Manager, Global Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
`
`
`Dear Ms. Terry:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated September 1, 2015,
`received September 1, 2015, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Cubicin (daptomycin for injection) 500 mg/vial.
`
`This “Prior Approval” supplement proposes revisions to the Post-Marketing Experience (6.2)
`subsection of the package insert to add “Special Senses: visual disturbances” to the list of
`adverse reactions and to Section 11, DESCRIPTION, to remove information on the amount of
`sodium hydroxide present.
`
`APPROVAL & LABELING
`
`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.
`
`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 (text for the package insert), 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.
`
`
`
`
`
`Reference ID: 3820457
`
`
`
`
`
`NDA 21-572/S-050
`Page 2
`
`
`
`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
`
` The SPL will be accessible from publicly available labeling repositories.
`
`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).
`
`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}
`
`
`Sumathi Nambiar, MD, MPH
`Director,
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE: Content of Labeling
`
`Reference ID: 3820457
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUMATHI NAMBIAR
`09/17/2015
`
`Reference ID: 3820457
`
`