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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-572/S-007
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`Cubist Pharmaceuticals, Inc.
`Attention: Karen L. Drake, Esq.
`Director, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Ms. Drake:
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`Please refer to your supplemental new drug applications dated September 7, 2005, received September
`8, 2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Cubicin®
`(daptomycin for injection) intravenous infusion, 500 mg/vial.
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`We also acknowledge receipt of your submission dated February 9, 2006, received February 10, 2006.
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`This “Changes Being Effected in 30 days” supplemental new drug application provides for the
`following revisions:
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`1. Removal of disk diffusion information from the label based on the results of Center for Disease
`Control (CDC) and Clinical Microbiology Institute of Oregon studies which have demonstrated
`a lack of correlation between daptomycin minimum inhibitory concentration (MIC) by broth
`microdilution and the zone diameter by disk diffusion for isolates with MIC values ≥ 2µg/mL.
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`2. Revised structure of daptomycin in the label to reflect the absolute configuration of the
`asparagine moiety in the side chain as dextrarotatory (D) instead of levarotatory (L).
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`3. Removal of Cubicin® (daptomycin for injection) 250 mg/vial NDC 67919-010-01 from the
`labeling text, as the 250 mg vial is no longer distributed.
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`4. Update of distributor location information in the label.
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`5. Addition of a US patent number to the label.
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`We completed our review of this application, as amended, and it is approved, effective on the date of
`this letter, for use as recommended in the agreed-upon labeling text and with the editorial revisions
`listed in the appended Microbiology portion of the package insert. The final printed labeling (FPL)
`must include the editorial revisions indicated. These revisions are terms of the approval of this
`application.
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`NDA 21-572/S-007
`Page 2
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission. "FPL for approved supplement NDA 21-572/S-007.” Approval of this submission by
`FDA is not required before the labeling is used.
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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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, Regulatory Project Manager, at (301) 796-0702.
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`MEDWATCH
`Food and Drug Administration
`WO 22, Room 4447
`10903 New Hampshire Avenue
`Silver Spring, MD 20993-0002
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`Sincerely,
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`{See appended electronic signature page}
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`James D. Vidra, PhD
`Chemistry Team Leader
`Division of Anti-Infective and Ophthalmology Products
`DNDC III, Office of New Drug Chemistry
`Center for Drug Evaluation and Research
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`Enclosure: FDA revisions to the Microbiology portion of package insert
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` submitted February 15, 2006
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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/
`---------------------
`Jim Vidra
`3/8/2006 10:02:43 AM
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