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`Public Health Service
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`Food and Drug Administration
`Rockville, MD 20857
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`NDA 50-790/S-001
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`Allergan, Inc.
`Attention: Elizabeth Bancroft
`Senior Director, Regulatory Affairs
`2525 Dupont Drive
`P.O. Box 19534
`Irvine, California 92623-9534
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`Dear Ms. Bancroft:
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`Please refer to your supplemental new drug application dated April 11, 2003, received April 14, 2003,
`submitted under the Federal Food, Drug, and Cosmetic Act for Restasis (cyclosporine ophthalmic
`emulsion), 0.05%.
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`We acknowledge receipt of your submissions dated April 15 and September 5, 2003.
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`This “Changes Being Effected” supplemental new drug application provides for a change to the
`product labeling.
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`We completed our review of this application, as amended. This application is approved for use as
`recommended in the agreed-upon labeling text.
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`However, if a future supplement is submitted, the trademark on the aluminum overcap should be
`revised to be more similar in prominence to the established name, in accordance with 21 CFR
`201.10(g)(2). We also recommend that you be consistent with the use of the phrase ‘RESTASIS
`ophthalmic emulsion’ throughout the package insert.
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`The final printed labeling (FPL) must be identical to the labeling text for the package insert and the
`outer aluminum overcap (enclosed), submitted September 5, 2003.
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`Please submit the FPL electronically according to the guidance for industry titled Providing Regulatory
`Submissions in Electronic Format – NDA. Alternatively, you may submit 20 paper copies of the FPL
`as soon as it is available, in no case more than 30 days after it is printed. Please individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, this submission
`should be designated "FPL for approved supplement NDA 50-790/S-001.” Approval of this
`submission by FDA is not required before the labeling is used.
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`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
`this division and two copies of both the promotional materials and the package insert directly to:
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`NDA 50-790/S-001
`Page 2
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`Division of Drug Marketing, Advertising, and Communications, HFD-42
`Food and Drug Administration
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`5600 Fishers Lane
`Rockville, MD 20857
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
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`If you have any questions, call Lori M. Gorski, Project Manager, at (301) 827-2090.
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`MEDWATCH, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
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`Enclosure
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`Sincerely,
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`{See appended electronic signature page}
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`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 Evaluation and Research
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`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Linda Ng
`9/16/03 03:11:34 PM
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