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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-011
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`Cubist Pharmaceuticals, Inc.
`Attention: Mary Beth Clark
`Director, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Ms. Clark:
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`Please refer to your supplemental new drug application dated August 11, 2006, received August 14,
`2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for CUBICIN®
`(daptomycin for injection).
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`This “Changes Being Effected in 30 days” supplemental new drug application provides for revisions to
`the “Post Marketing Experience” section of the labeling text, and in particular the addition of the
`adverse reaction “pulmonary eosinophilia” under “Immune System Disorders”.
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`We completed our review of this application and it is approved, effective on the date of this letter, for
`use as recommended in the agreed-upon labeling text. The final printed labeling (FPL) must be
`identical to the enclosed labeling submitted on August 11, 2006. Please submit an electronic version
`of the FPL according to the guidance for industry titled Providing Regulatory Submissions in
`Electronic Format - NDA. 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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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-572/S-011
`Page 2
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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, 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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`Janice M. Soreth, MD
`Director
`Division of Anti-Infective and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Enclosure: Labeling submitted on August 11, 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/
`---------------------
`Janice Soreth
`2/20/2007 04:49:45 PM
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