`
`AD M IN I STRATIO N
`
`• ,~~\.-
`
`
`NDA 021572/S-068
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Cubist Pharmaceuticals, LLC
`Attention: Shona P. Mehta, PhD
`Associate Director, Global Regulatory Affairs
`126 East Lincoln Avenue
`Mailstop RY34-A252
`Rahway, NJ 07065
`
`
`Dear Dr. Mehta:
`
`Please refer to your supplemental new drug application (sNDA) dated and recieved
`January 13, 2022, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Cubicin (daptomycin) for Injection.
`
`This Prior Approval sNDA provides for revisions to the prescribing information (PI) due
`to a lack of supporting information, as it relates to the use of Lactated Ringers in the
`
`reconstitution or dilution of Cubicin. Accordingly, revisions have been made to the
`HIGHLIGHTS OF PRESCRIBING INFORMATION, DOSAGE AND ADMINISTRATION
`
`(2.0) section, Preparation and Administration of CUBICIN (2.7) and Compatible
`Intravenous Solutions for Reconstitution and Dilution (2.8), subsections.
`
`
`
`We note this Prior approval Supplement was submitted in response to our December 3,
`2021, Prior Approval supplement request letter.
`
`APPROVAL & LABELING
`
`We have completed our review of this application and it is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information), with the addition of any labeling changes in pending “Changes
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
`
`in the enclosed labeling.
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`
`
`Reference ID: 4941961
`
`
`
`NDA 021572/S-068
`Page 2
`
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`REPORTING REQUIREMENTS
`
`
`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, Senior Regulatory Project
`
`Manager, at (301) 796-0702.
`
`
`
`
`
`
`
`ENCLOSURE: Prescribing Information
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Dmitri Iarikov, MD, PhD
`
`Deputy Director
`Division of Anti-Infectives
`Office of Infectious Diseases
`Center for Drug Evaluation and Research
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4941961
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`DMITRI IARIKOV
`02/23/2022 09:28:21 AM
`
`Reference ID: 4941961
`
`
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
