`RESEARCH
`
`APPLICA TION NUMBER:
`2 1 -994
`
`APPROVAL LETTER
`
`
`
`—/C DEPARTMENT OF HEALTH & HUMAN SERVICES
`"ah
`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21-994
`
`Alcon, Inc.
`c/o Alcon Research, Ltd.
`
`Attention: Angela C. Kothe, O.D., Ph.D.
`Associate Director, Regulatory Affairs
`Mail Code R7—1 8
`
`6201 South Freeway
`Fort Worth, Texas 76134-2099
`
`Dear Dr. Kothe:
`
`Please refer to your new drug application (NDA) dated November 18, 2005, received
`November 21, 2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`for Travatan Z (travoprost ophthalmic solution) 0.004%.
`
`We acknowledge receipt of your submissions dated November 18, and December 7 and 14, 2005, and
`January 10, March 15, July 25, August 15, and September 1, 6, 15, and 18, 2006.
`
`This new drug application provides for the use of Travatan Z for the reduction of elevated intraocular
`pressure in patients with open angle glaucoma or ocular hypertension who are intolerant of other
`intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP
`determined after multiple measurements over time) to other intraocular pressure lowering medications.
`
`We completed our review of this application, as amended. It is approved, effective on the date of this
`letter, for use as recommended in the agreed-upon labeling text.
`
`The final printed labeling (FPL) must be identical to the enclosed draft labeling submitted on
`September 15, 2006. Marketing the product with FPL that is not identical to the approved labeling text
`may render the product misbranded and an unapproved new drug. Please submit the content of the
`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 to the enclosed draft labeling. Upon
`receipt and verification, we will transmit that version to the National Library of Medicine for posting
`on the DailyMed website.
`
`
`
`NDA 21-994
`
`Page 2
`
`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`and this division and two copies of both the promotional materials and the package insert directly to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`Please submit one market package of the drug product when it is available.
`
`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 Michael Puglisi, Project Manager, at (301) 796-0791.
`
`Sincerely,
`
`[See appendedelectronic ylgfla/z/repdge/
`
`Janice M. Soreth, MD.
`Director
`Division of Anti-Infective and
`
`Ophthalmology Products
`Office of Antimicrobial Products
`
`Center for Drug Evaluation and Research
`
`Enclosure
`
`Appears This Way
`On Original
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Janice Soreth
`
`9/21/2006 03:22:29 PM
`
`Appears This Way
`On Original
`
`