`
`
`
`
` DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`
`
`
`
` Food and Drug Administration
`
`
`Rockville, MD 20857
`
`
`
`
`
`
`
`ANDA 79-110
`
`
`
`
`
`
`
`Kendle Regulatory Affairs
`
`U.S. Agent for: Sun Pharma Global Inc.
`
`Attention: Anthony C. Celeste
`
`Senior Vice President
`
`7361 Calhoun Place, Suite 500
`
`Rockville, MD 20855-2765
`
`
`
`Dear Sir:
`
`
`This is in reference to your abbreviated new drug application
`
`(ANDA) dated July 9, 2007, submitted pursuant to section 505(j)
`
`of the Federal Food, Drug, and Cosmetic Act (the Act), for
`
`Bicalutamide Tablets USP, 50 mg.
`
`
`Reference is also made to your amendments dated January 8,
`
`February 13, September 5, and November 21, 2008; and January 27,
`
`April 21, and June 8, 2009.
`
`
`We have completed the review of this ANDA and have concluded
`
`that adequate information has been presented to demonstrate that
`
`the drug is safe and effective for use as recommended in the
`
`submitted labeling. Accordingly the ANDA is approved, effective
`
`on the date of this letter. The Division of Bioequivalence has
`
`determined your Bicalutamide Tablets USP, 50 mg, to be
`
`bioequivalent and, therefore, therapeutically equivalent to the
`
`reference listed drug, Casodex Tablets, 50 mg, of AstraZeneca UK
`
`Limited. Your dissolution testing should be incorporated into
`
`the stability and quality control program using the same method
`
`proposed in your application.
`
`
`Under section 506A of the Act, certain changes in the conditions
`
`described in this ANDA require an approved supplemental
`
`application before the change may be made.
`
`
`We note that if FDA requires a Risk Evaluation & Mitigation
`
`Strategy (REMS) for a listed drug, an ANDA citing that listed
`
`drug also will be required to have a REMS, See 505-1(i).
`
`
`
`
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Division of Drug Marketing, Advertising, and Communications
`
`5901-B Ammendale Road
`
`Beltsville, MD 20705
`
`
`Postmarketing reporting requirements for this ANDA are set forth
`
`in 21 CFR 314.80-81 and 314.98. The Office of Generic Drugs
`
`should be advised of any change in the marketing status of this
`
`drug.
`
`
`Promotional materials may be submitted to FDA for comment prior
`
`to publication or dissemination. Please note that these
`
`submissions are voluntary. If you desire comments on proposed
`
`launch promotional materials with respect to compliance with
`
`applicable regulatory requirements, we recommend you submit, in
`
`draft or mock-up form, two copies of both the promotional
`
`materials and package insert directly to:
`
`
`
`
`
`
`
`
`We call your attention to 21 CFR 314.81(b)(3) which requires
`
`that all promotional materials be submitted to the Division of
`
`Drug Marketing, Advertising, and Communications with a completed
`
`Form FDA 2253 at the time of their initial use.
`
`
`
`
`Within 14 days of the date of this letter, submit updated
`
`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 in
`
`content to the approved labeling. Upon receipt and
`
`verification, we will transmit that version to the National
`
`Library of Medicine for public dissemination. For
`
`administrative purposes, please designate this submission as
`
`“Miscellaneous Correspondence – SPL for Approved ANDA 79-110”.
`
`
`
`
`Sincerely yours,
`
`
`
`{See appended electronic signature page}
`
`
`Gary Buehler
`
`Director
`
`Office of Generic Drugs
`
`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/
`
`---------------------
`Robert L. West
`
`7/6/2009 02:19:57 PM
`
`Deputy Director, for Gary Buehler
`
`
`
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
