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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-006
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`Cubist Pharmaceuticals, Inc.
`Attention: David Mantus, PhD
`Director, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Dr. Mantus:
`
`Please refer to your supplemental new drug application dated April 13, 2005, received April 14, 2005,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for CUBICIN®
`(daptomycin for injection) 250 mg/vial and 500 mg/vial.
`
`This supplemental new drug application provides for the addition of a Post-Marketing Experience
`subsection to the ADVERSE REACTIONS section of the labeling.
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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 minor editorial
`revisions to the PRECAUTIONS and ADVERSE REACTIONS sections, listed below:
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`In the subsection entitled “Drug Interactions,” under PRECAUTIONS, the following phrase
`should be added to the end of the paragraph under the heading, HMG CoA Reductase
`Inhibitors: “(see ADVERSE REACTIONS, Post-Marketing Experience).”
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`The following statements should be added to the Post-Marketing Experience subsection under the
`ADVERSE REACTIONS section:
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`“Post-Marketing Experience”
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`“The following adverse reactions have been reported with CUBICIN in worldwide post-
`marketing experience. Because these events are reported voluntarily from a population of
`unknown size, estimates of frequency cannot be made and causal relationship cannot be
`precisely established.
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`“Immune System Disorders: Anaphylaxis; hypersensitivity reactions, including pruritus,
`hives, shortness of breath, difficulty swallowing, and truncal erythema.
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`“Musculoskeletal System: Rhabdomyolysis; some reports involved patients treated
`concurrently with CUBICIN and HMG CoA reductase inhibitors.”
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`NDA 21-572/S-006
`Page 2
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`The final printed labeling (FPL) must be identical, and include the minor editorial revisions indicated,
`to the enclosed labeling submitted April 13, 2005 and dated August 2004. These revisions are terms of
`the approval of this application.
`
`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-006.” 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, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
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`Sincerely,
`
`{See appended electronic signature page}
`
`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 April 13, 2005
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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
`10/14/2005 01:55:22 PM
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