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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVALS
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`NDA 21-572/S-022
`NDA 21-572/S-023
`NDA 21-572/S-024
`NDA 21-572/S-027
`NDA 21-572/S-030
`NDA 21-572/S-032
`
`
`Cubist Pharmaceuticals, Inc.
`Attention: David S. Mantus, Ph.D.
`Vice President, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
`
`Dear Dr. Mantus:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated July 29, 2008 (S-022),
`August 1, 2008 (S-023), September 19, 2008 (S-024), June 30, 2009 (S-027), December 22,
`2009 (S-030), and February 17, 2010 (S-032), submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Cubicin (daptomycin for injection), 500 mg/vial.
`
`We also acknowledged receipt of your amendments dated October 1 and 20, 2010 (S-023) and
`your labeling amendment dated November 30, 2010. The October 1, 2010, amendment
`constituted a complete response to our action letter dated March 18, 2010.
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`These supplemental new drug applications provide for the following:
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`• NDA 21-572/S-022: Revisions to the “Post-Marketing Experience” section of the
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`labeling text.
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`• NDA 21-572/S-023: An alternative method of administration of reconstituted CUBICIN
`at a concentration of 50 mg/mL as an IV bolus injection over approximately 2 minutes.
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`• NDA 21-572/S-024: Revisions to the “CLINICAL PHARMACOLOGY, Drug-Drug
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` Interactions, Aztreonam” section of the labeling text.
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`• NDA 21-572/S-027: Proposed content of the label in Physician’s Labeling Rule (PLR)
`format.
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`• NDA 21-572/S-030: Revisions to the proposed PLR format (S-027) of the label to
`provide additional information on patients with moderate to severe renal impairment.
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`Reference ID: 2870481
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` NDA 21-572/S-022
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` NDA 21-572/S-023
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` NDA 21-572/S-024
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` NDA 21-572/S-027
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` NDA 21-572/S-030
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` NDA 21-572/S-032
`Page 2
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`• NDA 21-572/S-032: Revisions to Section 6.2 (Post-Marketing Experience) of the
`proposed PLR-format label to add the adverse reaction “Clostridium difficile–
`associated diarrhea” under “Infections and Infestations.”
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`
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`We have completed our review of these supplemental applications, as amended and they are
`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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`
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert, text for the patient package insert,
`Medication Guide) and include the labeling changes proposed in any pending “Changes Being
`Effected” (CBE) supplements and any 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.
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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 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.
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`Reference ID: 2870481
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` NDA 21-572/S-022
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` NDA 21-572/S-023
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` NDA 21-572/S-024
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` NDA 21-572/S-027
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` NDA 21-572/S-030
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` NDA 21-572/S-032
`Page 3
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` LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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` MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`
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`REPORTING REQUIREMENTS
`
`
`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,
`
` {See appended electronic signature page}
`
` Katherine A. Laessig, MD
`Deputy Director
`Division of Anti-Infective and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of labeling dated November 30, 2010
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`Reference ID: 2870481
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`
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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/
`----------------------------------------------------
`
`KATHERINE A LAESSIG
`11/30/2010
`
`Reference ID: 2870481
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`
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