,.-...
`i .~ Ii U.S. FOOD & DRUG
`
`ADMINISTRATION
`
`\,~ ~
`
`NDA 020965/S-017
`
`SUPPLEMENT APPROVAL
`
`DUSA Pharmaceuticals, Inc.
`Attention: Scott Lundahl
`Associate Vice President, Regulatory Affairs and Intellectual Property
`29 Dunham Road
`Billerica, MA 01821
`
`Dear Dr. Lundahl:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`December 28, 2018, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Levulan Kerastick (aminolevulinic acid HCl) for topical
`solution, 20%.
`
`This “Changes Being Effected” sNDA provides for an updated patient package insert
`(PPI) to include the risk of temporary memory problems as a possible side effect of use.
`This change was made to be consistent with the Prescribing Information (PI)
`supplement previously approved on April 19, 2018.
`
`APPROVAL & LABELING
`
`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Patient Package Inser), with the addition of any labeling changes in pending “Changes
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
`in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`Reference ID: 4980021
`
`
`i .~ Ii U.S. FOOD & DRUG
`
`ADMINISTRATION
`
`\,~ ~
`
`NDA 020965/S-017
`
`SUPPLEMENT APPROVAL
`
`DUSA Pharmaceuticals, Inc.
`Attention: Scott Lundahl
`Associate Vice President, Regulatory Affairs and Intellectual Property
`29 Dunham Road
`Billerica, MA 01821
`
`Dear Dr. Lundahl:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`December 28, 2018, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Levulan Kerastick (aminolevulinic acid HCl) for topical
`solution, 20%.
`
`This “Changes Being Effected” sNDA provides for an updated patient package insert
`(PPI) to include the risk of temporary memory problems as a possible side effect of use.
`This change was made to be consistent with the Prescribing Information (PI)
`supplement previously approved on April 19, 2018.
`
`APPROVAL & LABELING
`
`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Patient Package Inser), with the addition of any labeling changes in pending “Changes
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
`in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`Reference ID: 4980021
`
`
`
`NDA 020965/S-017
`Page 2
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`All promotional materials that include representations about your drug product must be
`promptly revised to be consistent with the labeling changes approved in this
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`in your promotional materials should include prominent disclosure of the important new
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4980021
`
`
`
`NDA 020965/S-017
`Page 3
`
`If you have any questions, call Jennifer Harmon, Regulatory Project Manager, at
`240-402-4880.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Tatiana Oussova, MD, MPH
`Deputy Director for Safety
`Division of Dermatology and Dentistry
`Office of Immunology and Inflammation
`Office of New Drugs
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S): Content of Labeling - Patient Package Insert
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4980021
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`■
`
`TATIANA OUSSOVA
`05/09/2022 01:05:28 PM
`
`Reference ID: 4980021
`
`(
`
`
`
`
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