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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-004
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`DUSA Pharmaceuticals, Inc.
`Attention: Scott Lundahl
`Director, Regulatory Affairs (Acting)
`25 Upton Drive
`Wilmington, MA 01887
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`Dear Mr. Lundahl:
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`Please refer to your supplemental new drug application dated March 11, 2003, received March 12,
`2003, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for LEVULAN®
`KERASTICK® (aminolevulinic acid hydrochloride) for Topical Solution, 20%.
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`This supplemental new drug application provides for a new manufacturing site for the production of
`LEVULAN® KERASTICK® for Topical Solution finished drug product.
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`We have completed our review of this application. This application is approved, effective on the date
`of this letter, for use as recommended in the agreed-upon labeling text and with the minor editorial
`revisions indicated in the submitted labeling.
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`The final printed labeling (FPL) must be identical to the enclosed labeling (for the text of the package
`insert) and to the submitted labeling (immediate container and carton labels submitted March 11, 2003)
`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-004.” 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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`Division of Drug Marketing, Advertising, and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
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`NDA 20-965/S-004
`Page 2
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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 Jacquelyn Smith, Regulatory Project Manager, at (301) 827-2020.
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`MEDWATCH, HF-2
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
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`Sincerely,
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`{See appended electronic signature page}
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`Wilson H. DeCamp II, Ph.D.
`Chemistry Team Leader for the
`Division of Dermatologic & Dental Drug Products, (HFD-540)
`DNDC III, Office of New Drug Chemistry
`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/
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`Steve Hathaway
`7/11/03 12:34:18 PM
`Signed on behalf of W H DeCamp, as Acting CMC Team Leader
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