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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-770
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`Allergan, Inc.
`Attention: Lewis Gryziewicz, R.Ph.
`Director, Pharmaceutical Regulatory Affairs
`2525 Dupont Drive
`P.O. Box 19534
`Irvine, California 92623-9534
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`Dear Mr. Gryziewicz:
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`Please refer to your new drug application (NDA) dated May 27, 2004, received June 1, 2004,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Alphagan P
`(brimonidine tartrate ophthalmic solution) 0.1%.
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`We acknowledge receipt of your submissions dated April 1, June 27, July 20, and August 3, 17, and
`18, 2005.
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`The June 27, 2005, submission constituted a complete response to our April 1, 2005, action letter.
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`This new drug application provides for the use of Alphagan P (brimonidine tartrate ophthalmic
`solution) 0.1%, for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular
`hypertension.
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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 agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed draft labeling submitted
`August 17, 2005. 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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`The electronic labeling rule published December 11, 2003, (68 FR 69009) requires submission of
`labeling content in electronic format effective June 8, 2004. For additional information, consult the
`following guidances for industry regarding electronic submissions: Providing Regulatory
`Submissions in Electronic Format - NDAs (January 1999) and Providing Regulatory Submissions in
`Electronic Format – Content of Labeling (February 2004). The guidances specify that labeling is to
`be submitted in pdf format. To assist in our review, we request that labeling also be submitted in MS
`Word format. If formatted copies of all labeling pieces (i.e., package insert, container labels, and
`carton labels) are submitted electronically, labeling does not need to be submitted in paper.
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`Division of Drug Marketing, Advertising,
`and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
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`NDA 21-770
`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 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 Michael Puglisi, Project Manager, at (301) 827-2090.
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`Sincerely,
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`{See appended electronic signature page}
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`Janice M. Soreth, M.D.
`Director
`Division of Anti-Infective and
`Ophthalmology Products, HFD-520
`Office of Drug Evaluation IV
`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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`Lillian Gavrilovich
`8/19/2005 09:17:29 AM
`Signing for Dr. J. Soreth.
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