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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-014
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`Cubist Pharmaceuticals, Inc.
`Attention: David S. Manus, PhD
`Vice President, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Dr Mantus:
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`Please refer to your supplemental new drug application dated March 23, 2007, received March 26,
`2007 submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for CUBICIN®
`(daptomycin for injection) 500 mg/vial.
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`This “Changes Being Effected” supplemental new drug application provides for revisions to the
`package insert to include information relative to recent epidemiologic and scientific data regarding
`Clostriduim difficile associated disease (CDAD).
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`We have completed our review of this application. It is approved, effective on the date of this letter,
`for use as recommended in the content of labeling [21 CFR 314.50(1)] in structured product labeling
`(SPL) format submitted on March 23, 2007.
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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-014
`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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`Enclosure: Labeling submitted on March 23, 2007
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`Sincerely,
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`{See appended electronic signature page}
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`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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`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
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`Kathrine Laessig
`10/5/2007 02:59:08 PM
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