`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`
`
`
`
`
`
`
`
`
`
`NDA 21-572/S-014
`
`
`
`Cubist Pharmaceuticals, Inc.
`Attention: David S. Manus, PhD
`Vice President, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
`
`
`Dear Dr Mantus:
`
`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.
`
`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).
`
`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.
`
`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:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
`
`
`
`NDA 21-572/S-014
`Page 2
`
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`If you have any questions, call J. Christopher Davi, MS, Regulatory Project Manager, at (301) 796-
`0702.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Enclosure: Labeling submitted on March 23, 2007
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Katherine A. Laessig, MD
`Deputy Director
`Division of Anti-Infective and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Kathrine Laessig
`10/5/2007 02:59:08 PM
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
