`
`".1qu1’0‘1
`
`-/C DEPARTMENTOFHEALTHANDHUMAN SERVICES
`
`i5
`
`.-8
`
`QJ
`
`Food and Drug Administration
`Silver Spring, MD 20993
`
`SUPPLEMENT APPROVAL
`
`NDA 203341/8-013
`
`Pf Prism C .V.
`
`c/o Pfizer Inc.
`
`Attention: Bhanu Purohit, M.S
`
`Global Regulatory Lead, Worldwide Safety and Regulatory
`445 Eastern Point Road, MS 8260-1118
`
`Groton, CT 06340
`
`Dear Ms. Purohit:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received November 3,
`2017, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Bosulif® (bosutinib) Tablets.
`
`This “Changes Being Efimted in 30 days” supplemental new drug application provides for the
`addition of professional sample container label for bosutinib 400 mg tablets.
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to enclosed carton and
`immediate container labels, as soon as they are available, but no more than 30 days after they are
`printed. Please submit these labels electronically according to the guidance for industry Providing
`Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and
`Related Submissions Using the eCTD Specifications (May 2015, Revision 3). For administrative
`purposes, designate this submission “Product Correspondence — Final Printed Carton and
`Container Labels for approved NDA 203341/S—013.” Approval of this submission by FDA is
`not required before the labeling is used.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`
`
`NDA 203341/S-013
`Page 2
`
`If you have any questions, call Adijat Abass-Fasuyi, Regulatory Business Process Manager, at
`(301) 796 - 3609.
`
`
`
`
`Enclosure:
`Carton and Container Labeling
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Ramesh Raghavachari, Ph.D.
`Chief, Branch I
`Division of Post-Marketing Activities I
`Office of Lifecycle Drug Products
`Office of Pharmaceutical Quality
`Center for Drug Evaluation and Research
`
`
`
`
`
`Ramesh
`Raghavachari
`
`Digitally signed by Ramesh Raghavachari
`Date: 5/01/2018 09:41:35PM
`GUID: 502d0913000029f375128b0de8c50020
`
`(
`
`
`
`
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
