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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-010
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`Cubist Pharmaceuticals, Inc.
`Attention: Prabu Nambiar, PhD, MBA, RAC
`Senior Director, CMC Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Dr. Nambiar,
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`Please refer to your supplemental new drug application dated August 2, 2006, received August 3,
`2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for CUBICIN®
`(daptomycin for injection).
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`We also acknowledge receipt of your draft labeling submission dated February 5, 2007, which
`constitutes a complete response to our approval letter dated October 24, 2006 (S-009), and incorporates
`proposed revisions to the “Preparation of CUBICIN for Administration” section of the package
`insert, which have been submitted for approval as a provision of this supplement (S-010).
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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 draft labeling submitted on February 5, 2007.
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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. 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-010
`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, Regulatory Project Manager, at (301) 796-0702.
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`Enclosure: Draft labeling submitted on February 5, 2007
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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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`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
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` /s/
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`Janice Soreth
`2/12/2007 08:09:19 AM
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