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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-003 & S-004
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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 applications dated June 30, 2003, received July 1, 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 July 30, August 15 and September 16, 2003.
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`These “Changes Being Effected in 30 days” supplemental new drug applications provide for embossed
`letters on the product vial to replace a paper label.
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`We have completed our review of these supplemental new drug applications, as amended. These
`supplements are approved.
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`We remind you that you must comply with the 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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`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.
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` /s/
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`Linda Ng
`10/1/03 05:13:54 PM
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