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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 20965/S-006
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`DUSA Pharmaceuticals, Inc.
`Attention: Scott Lundahl
`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 November 19, 2007, received
`November 20, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Levulan® Kerastick® (aminolevulinic acid HCl) Topical Solution, 20% for treatment of minimally to
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`moderately thick actinic keratoses of the face or scalp.
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`We acknowledge receipt of your submission dated May 2, 2008.
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`This supplemental new drug application provides for modification of the “Dosage and Administration”
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`section of the approved product labeling to allow for the user to mix the contents of the ampoules prior
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`to use in a period of 30 seconds rather than the current 3 minute mixing time. In addition, this
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`supplement proposes revised labeling that supports the use of a new tool, the “Kerastick Krusher”,
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`which assists the user in crushing the ampoules prior to admix.
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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 patient package insert submitted
`November 19, 2007.
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
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`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
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`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
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`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission "FPL for approved supplement NDA 20-965/S-006.” Approval of this submission by
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`the 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
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`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`the Division of Dermatology and Dental Products and two copies of both the promotional materials
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`and the package insert directly to:
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`APPROVAL LETTER
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`NDA 20-965/S-006
`Page 2
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
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`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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`MEDWATCH
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`Food and Drug Administration
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`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
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`314.80 and 314.81).
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`If you have any questions, call Elaine Smoot, Regulatory Project Manager, at (301) 796-3986.
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`Sincerely,
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` {See appended electronic signature page}
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`Stanka Kukich, M.D.
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` Deputy Director
`Division of Dermatology and Dental Products
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` Office of Drug Evaluation III
`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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`Stanka Kukich
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`7/17/2009 12:13:35 PM
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