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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 21-572/S-021
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`Cubist Pharmaceuticals, Inc.
`Attention: Karen L. Drake, Esquire
`Senior Director, Regulatory Affairs
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`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Ms. Drake:
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`Please refer to your supplemental new drug application dated June 27, 2008 received June 30, 2008,
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`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for CUBICIN®
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`(daptomycin for injection).
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`We acknowledge receipt of your submission dated September 17, 2008, and your electronic mail
`correspondence dated February 6, 2009.
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`This “Changes Being Effected in 30 days” supplemental new drug application provides for revisions to
`the “Preparation of CUBICIN® for Administration” section of the package insert. Specifically, a new
`been added advising that CUBICIN® should not be used in conjunction with
`paragraph has
`ReadyMED® e
`lastomeric infusion pumps.
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` our review of this application as amended, and it is approved effective on the date of We completed
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`use as recommended in the agreed-upon labeling text, and with the minor editorial this letter, for
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` below: revisions listed
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`• Your o
`riginally proposed language to be added to the “Preparation of CUBICIN® for
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`istration” section:
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`Admin
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`•
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`Is to be replaced with the following language:
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`"CUBICIN should not be used in conjunction with ReadyMED® elastomeric infusion
`pumps (Cardinal Health, Inc.). Stability studies of CUBICIN solutions stored in
`ReadyMED® elastomeric infusion pumps identified an impurity (2
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`mercaptobenzothiazole) leaching from this pump system into the CUBICIN solution."
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`(b)
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`(4
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`NDA 21-572/S-021
`Page 2
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`As soon as possible, but no later than 14 days from the date of this letter, please submit the content of
`labeling [21 CFR 314.50(1)] in structured product labeling (SPL) format as described at
`http://www.fda.gov/oc/datacouncil/spl.html that is identical to the label submitted June 27, 2008 (with
`the exception of the above listed minor editorial revisions). Upon receipt, we will transmit that version
`to the National Library of Medicine for public dissemination. For administrative purposes, designate
`this submission "SPL for approved supplement NDA 21-572/S-021.”
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` If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
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`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
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` Food and Drug Administration
`Suite 12B05
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` 5600 Fishers Lane
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`Rockville, MD 20857
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`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
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`314.80 and 314.81).
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`If you have any questions, call J. Christopher Davi, MS, Senior Regulatory Project Manager, at (301)
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`796-0702.
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`Sincerely,
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` {See appended electronic signature page}
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`Sumathi Nambiar, MD, MPH
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` Deputy Director for Safety
`Division of Anti-Infective and Ophthalmology Products
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` 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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`---------------------
`Sumathi Nambiar
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`2/10/2009 03:52:47 PM
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