DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-023
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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 new drug application (NDA) dated February 24, 1999, received February 25, 1999,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Restasis
`(cyclosporine ophthalmic emulsion) Ophthalmic Emulsion, 0.05%.
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`We acknowledge receipt of your submissions dated September 7, 2001, and April 23, May 22,
`June 17, July 11, September 6, October 28, November 15, and December 4, 6, 16 and 20, 2002.
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`We also refer to our approvable letters of August 3, 1999, and March 25, and October 19, 2000.
`The September 6, 2002, submission constituted a complete response to our October 19, 2000, action
`letter.
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`This new drug application provides for the use of Restasis (cyclosporine ophthalmic emulsion)
`Ophthalmic Emulsion, 0.05% for the following indication: to increase tear production in patients
`whose tear production is presumed to be suppressed due to ocular inflammation associated with
`keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical
`anti-inflammatory drugs or using punctal plugs.
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`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 enclosed labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed labeling text for the package insert,
`immediate container and carton labels. Marketing the product with FPL that is not identical to the
`approved labeling text may render the product misbranded and an unapproved new drug.
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`Please submit an electronic version of the FPL 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 but no more than 30 days after it is printed. Individually mount ten
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “FPL for approved NDA 21-023.” Approval of this submission by FDA is not required
`before the labeling is used.
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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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`NDA 21-023
`Page 2
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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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`Please submit one market package of the drug product when it is available.
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`We have not completed validation of the regulatory methods. However, we expect your continued
`cooperation to resolve any problems that may be identified.
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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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`Sincerely,
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`{See appended electronic signature page}
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`Wiley A. Chambers, M.D.
`Deputy Director
`Division of Anti-Inflammatory, Analgesic
`and Ophthalmic Drug Products, HFD-550
`Office of Drug Evaluation V
`Center for Drug Evaluation and Research
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`Enclosure
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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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`Wiley Chambers
`12/23/02 05:06:41 PM
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