`
`APPLICA TI0N NUMBER:
`
`50-790 / 8-002
`
`' APPROVAL LETTER
`
`
`
`silvlc
`a,”
`
`93‘“
`
`g: .6 DEPARTMENTOFHEALTH&HUMANSERVICES
`
`1,,
`
`publicHealthService
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 50-790/S-002
`
`Allergan, Inc.
`Attention: Elizabeth Bancrofi
`
`Senior Director, Regulatory Affairs
`2525 Dupont Drive
`PO. Box 19534
`
`Irvine, California 92623-9534
`
`Dear Ms. Bancroft:
`
`Please refer to your supplemental new drug application dated June 27,. 2003, received June 30, 2003,
`submitted under the Federal Food, Drug, and'Cosmetic Act for Restasis (cyclosporine ophthalmic
`emulsion), 0.05%.
`'
`
`This application is subject to the exemption provisions contained in section 125(d)(2) of Title I of the
`FDA Modernization Act of 1997.
`
`We acknowledge receipt of your submission dated July 29, 2003.
`
`p This “Changes Being Effected in 30 days” supplemental new drug application provides an additional
`
`We completed our review of this supplemental new drug application, as amended. This supplement is
`_ approved.
`
`-
`
`’We remind you that you must comply with the reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`‘
`,
`
`If you have any questions, call Lori M. Gorski, Regulatory Project Manager, at (301) 827-2090.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Linda L. Ng, Ph.D.
`Chemistry Team Leader, for the
`Division of Anti-Inflammatory, Analgesic ’
`and Ophthalmic Drug Products, HFD-550
`DNDC III, Office of New Drug Chemistry
`Center for Drug Evali1ation and Research
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Linda Ng
`9/12/03 05:24:23 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
