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`Public Health Service
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`Food and Drug Administration
`Rockville, MD 20857
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`NDA 20-965/S-003
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`DUSA Pharmaceuticals
`Attention: William R. McIntyre, Ph.D.
`Regulatory Consultant
`400 Columbus Avenue
`Valhalla, New York 10595
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`Dear Dr. McIntyre:
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`Please refer to your supplemental new drug application dated July 1, 2002, received July 2, 2002 submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for Levulan (aminolevulinic acid HC1) Kerastick for Topical
`Solution, 20%.
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`We acknowledge receipt of your correspondence dated March 28, 2003, received April 2, 2003 in response to the March
`28, 2003 action letter. We also acknowledge receipt of your correspondence dated May 12, 2003.
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`This supplemental new drug application provides for revisions in the CLINICAL PHARMACOLOGY/Clinical Studies,
`INDICATIONS AND USAGE, and PREPARATION sections of the package insert.
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`We completed our review of this application, as amended. This application 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 labeling (text for the package insert) and must be
`formatted in accordance with the requirements of 21 CFR 201.66. 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 ten of the copies on heavy-weight paper or similar material. For administrative purposes, this
`submission should be designated "FPL for approved supplement NDA 20-965/S-003.” 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 the Division of Dermatologic and Dental
`Drug Products and two copies of both the promotional materials and the package insert directly to:
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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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`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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`MEDWATCH, HF-2
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
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`NDA 20-965/S-003
`Page 2
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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 Jacquelyn Smith, Regulatory Project Manager, at (301) 827-2020.
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`Sincerely,
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`{See appended electronic signature page}
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` Jonathan K. Wilkin, M.D.
` Director
` Division of Dermatologic & Dental Drug Products
` 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.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`John Kelsey
`6/27/03 01:46:49 PM
`for Dr. Wilkin
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