DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 20-965/S-002
`
`DUSA Pharmaceticals, Incorporated
`Attention: William R. McIntyre, Ph.D.
`Regulatory Consultant
`400 Columbus Avenue
`Valhalla, New York 10595
`
`Dear Dr. McIntyre:
`
`Please refer to your supplemental new drug application dated February 6, 2002, received February 11, 2002 submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Levulan(cid:226)
` (aminolevulinic acid HC1) for Topical
`Solution, 20%.
`
`This “Changes Being Effected” supplemental new drug application provides for the Package Insert to be updated to include
`the statement “Excessive irritation may be experienced if this product is applied under occlusion” under the Warning
`section.
`
`We completed our review of the supplemental new drug application. It is approved, effective on the date of this letter, for
`use as recommended in the final printed labeling (FPL) submitted on May 17, 2002.
`
`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:
`
`Division of Drug Marketing, Advertising, and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
`
`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:
`
`MEDWATCH, HF-2
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81).
`
`If you have any questions, call Jacquelyn Smith, Regulatory Project Manager, at (301) 827-2020.
`
`Sincerely,
`
`{See appended electronic signature page}
`
` Jonathan K. Wilkin, M.D.
` Director
` Division of Dermatologic & Dental Drug Products
` Office of Drug Evaluation V
` Center for Drug Evaluation and Research
`
`Enclosure
`
`

`

`---------------------------------------------------------------------------------------------------------------------
`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
`3/26/03 01:14:34 PM
`for Dr. Wilkin
`
`