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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`NDA 020965/S-007
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`DUSA Pharmaceuticals, Inc.
`Attention: Scott Lundahl
`Vice President Regulatory Affairs/Intellectual Property
`25 Upton Drive
`Wilmington, MA 01887
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`Dear Mr. Lundahl:
`
`Please refer to your supplemental new drug application dated May 13, 2009, received May 13,
`2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20%.
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`
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`We acknowledge receipt of your submissions dated June 17, June 18, June 22, June 25, July 6,
`July 7, October 28, and February 26, 2010.
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`This “Prior Approval” supplemental new drug application provides for revisions to the Clinical
`Studies section of the labeling. In addition, Levulan® Kerastick® for Topical Solution full
`prescribing information was revised to meet the new labeling content and format requirements
`for human prescription drug and biological products according to 21 CDR 201.56(d) and 201.57.
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`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, please submit the
`content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format as
`described at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed
`labeling (text for the package insert). For administrative purposes, please designate this
`submission, “SPL for approved NDA 020965/S-007.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you issue a letter communicating important safety related information about this drug product
`(i.e., a “Dear Health Care Professional” letter), we request that you submit an electronic copy of
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`the letter to both this NDA and to the following address:
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`

`

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` NDA 020965/S-007
`Page 2
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`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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`REPORTING REQUIREMENTS
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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 Jeannine M. Helm, Regulatory Project Manager, at
`(301) 796-0637.
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`Sincerely,
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`{See appended electronic signature page}
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`Susan J. Walker, M.D., F.A.A.D.
`Director
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`Division of Dermatology and Dental Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`Enclosure
`Content of Labeling
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`Application
`Type/Number
`--------------------
`NDA-20965
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`Submission
`Type/Number
`--------------------
`SUPPL-7
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`Submitter Name
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`Product Name
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`------------------------------------------
`--------------------
`LEVULAN
`DUSA
`PHARMACEUTICA KERASTICK(AMINOLEVULINIC
`LS INC
`ACID HC
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUSAN J WALKER
`03/12/2010
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