CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICATION NUMBER:
`
`20-965
`
`ADMINISTRATIVE DOCUMENTS
`
`
`
`

`

`02-DEC-1999
`
`FDA CDER EES
`
`Page
`
`1 of
`
`ESTABLISHIVIENT EVALUATION REQUEST
`SUMMARY REPORT
`
`NDA 20965/000
`Application:
`Stamp: 01-JUL-1998 Regulatory Due: 04-DEC-1999
`Applicant:
`DUSA
`400 COLUMBUS AVE
`
`ls
`Priority:
`Action Goal:
`Brand Name:
`
`Org Code: 540
`District Goal: 02-MAR-1999
`
`LEVULAN
`KERASTICK(AMINOLEVULINIC
`ACID HC
`
`VALHALLA, NY 10595
`
`Established Name:
`
`Generic Name: AMINOLEVULINIC ACID HCL
`
`Dosage Form:
`Strength:
`
`SOL (SOLUTION)
`20%
`
`FDA Contacts:
`
`0. CINTRON
`
`(HFD-540)
`
`301-827-2023 , Project Manager
`
`.1. HATHAWAY
`
`(RFD-540)
`
`301-827-2069 , Review Chemist
`
`W. DECAMP II
`
`(RFD-540)
`
`301-827-2041
`
`, Team Leader
`
`Overall Recommendation:
`
`ACCEPTABLE on lZ-NOV-l999 bv M. EGAS (HFD-322) 301-594-0095
`
`\VITHHOLD on 07-APR-l999 bv J. D AMBROGIO (RFD-324) 301-827-0062
`
`DMF 1402:)
`Establishment: 1052961
`GUIDELINES ANALYTICAL LABORA AADA No:
`
`10320 USA TODAY WAY
`
`MIRIMAR, FL 33025
`
`0A1 giants; NONE
`(:11
`Profile;
`Last Milestone: 0c RECOMMENDATION
`Milestone Date: 28-JUL-I998
`Decision:
`ACCEPTABLE
`
`Reason:
`
`BASED ON PROFILE
`
`Establishment: 1217998
`
`NORTH SAFETY PRODUCTS
`2000 PLAINFIELD PIKE
`
`CRANSTON,RI 02920 ..
`
`0A1 Status: NONE
`Profile; LlQ
`Last Milestone: 0c RECOMMENDATION
`Milestone Date: 07-APR-I999
`
`Decision:
`
`ACCEPTABLE
`
`Responsibilities: FINISHED DOSAGE STABILITY
`TESTER
`
`DMF No:
`
`AADA No:
`
`Responsibilities: FINISHED DOSAGE
`MANUFACTURER
`
`Reason:
`DISTRICT RECOMMENDATION
`
`
`Establishment
`
`DMF No:\:::)
`AADA No:
`
`Profile: CSN
`
`OAl Status: NONE
`
`

`

`02-DEC- I 999
`
`FDA CDER EES
`
`Page
`
`20f
`
`IQ
`
`ESTABLISHMENT EVALUATION REQUEST
`SUMMARY REPORT
`
`Last Milestone:
`
`Milestone Date:
`
`Decision:
`
`Reason:
`
`0C RECOMMENDATION
`04.Nov-1999
`ACCEPTABLE
`
`DISTRICT RECOMMENDATION
`
`Responsibilities: DRUG SUBSTANCE
`MANUFACTURER
`
`APPEARS THIS WAY
`(IN ORIGINAL
`
`'
`
`

`

`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`
`33.»? ELI: 33303? WW"
`. USER FEE COVER SHEET
`
`See Instructions on Reverse Side Before Completing 777i: Form
`APPLICANTS NAME AND ADDRESS
`
`(APPUCATION NO. CONTAINING THE DATA). ( 914 )
`
`lF yOUR RESPONSE Is No- AND THIS IS FOR A SUPPLEMENT. STOP HERE
`AND SIGN THIS FORM.
`
`IF RESPONSE IS 'YES'. CHECK THE APPROPRIATE RESPONSE BELOW:
`
`[X] THE REQUIRED CLINICAL DATA ARE CONTAINED IN THE APPLICATION.
`D THE REQUIRED CLINICAL. DATA ARE SUBMITTED BY
`REFERENCE TO
`
`[USA Pharmaceutical s,,.lnc.
`4(1) CO] urbus AW
`Va] MI I a , NY 10595
`
`2. TELEPHONE NUMBER (m Am cone;
`
`747-41”
`
`5. USER FEE LD. NUMBER
`' 3494
`
`5. LICENSE NUMBER I NDA NUMBER
`20-965
`
`7.
`
`IS THIS APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCLUSIONS? IF SO. CHECK THE APPLICABLE EXCLUSION.
`
`D A LARGE VOLUME PARENTERAL DRUG PRODUCT
`APPROVED UNDER SECTION 505 OF THE FEDERAL
`FOOD. DRUG. AND COSMETIC ACT BEFORE 9/1/92
`(Sell Exflanarory)
`
`D A 505(b)(2) APPUCATION THAT DOES NOT REQUIRE A FEE
`(See item 7. reverse side Dem My box.)
`
`D THE APPUCAT‘ION OUALIFIES FOR THE ORPHAN
`EXCEPTION UNDER SECTION 736(c)(1)(E) OI the Federal Food.
`Drug. and Cosmetic Act
`(SuireereverseskieeeloredieothgbaxJ
`
`D THE APPUCATION IS A PEDIATRIC SUPPLEMENT THAT
`OUALIFIES FOR THE EXCEPTION UNDER SECTION 736(a)(1)(F) oi
`the Federal Food. Drug. and Cosmetic Act
`(SeeMZmeidebeihrediecln’ngboa)
`
`+‘i’W'W’W'T’V‘ '
`
`'
`
`W.M"—'—
`
`APPLICATION IS SUBMITTED BY A STATE OR FEDERAL
`
`GOVERNMENT ENTITY FOR A DRUG THAT IS NOT DISTRIBUTED
`COMMERCIALLY
`(Sell Eulanerory)
`
`FOR BIOLOGICAL PRODUCTS ONLY
`
`U WHOLE BLOOD OR BLOOD COMPONENT FOR
`TRANSFUSION
`
`C] A CRUDE ALLERGENIC EXTRACT PRODUCT
`
`D AN APPUCATION FOR A BIOLOGICAL PRODUCT
`FOR FURTHER MANUFACTURING USE ONLY
`
`D AN 'IN VITRO' DIAGNOSTIC BIOLOGICAL PRODUCT
`LICENSED UNDER SECTION 351 OF THE PHS ACT
`
`a. HAS A WAIVER OF AN APPLICATION FEE BEEN GRANTED FOR THIS APPLICATION?
`
`D YES
`
`m NO
`
`I] BOVINE BLOOD PRODUCT FOR TOPICAL
`APPUCATION LICENSED BEFORE Git/92
`
`
`
`
`
`A completed form must be signed and accompany each new drug or biologic product application and each new
`supplement. Ifpayment Is sent by 0.5. mall or courier, please include a copy of this completed form with payment.
`
`
`
`
`
`Public reporting burden tor thle collection of Information is estimated to average 30 minutes per response. 'ncluding the time tor reviewing
`instructions. searching existing data sources. gathering and maintaining the data needed. and completing and reviewrng the collection of intormaion.
`Send comments regarding this burden estimate or any other aspect of this collection of Intormation. including suggestion tor reducing this burden to:
`
`DHHS.ReponsCIearanceOflIcer
`Paperwork Reduction Project (0910-0297)
`Hubert H. Humphrey Building. Room sat-H
`200 Independence Avenue. SW.
`Washington, Dc 20201
`
`AnagencymaynotoonductoreponeorJndapersonlsnol
`required to respond to. a collection at information unless It
`displays a currently valid OMB control lumber.
`
`i
`
`PleaseDO NOTRETURNttiietorrntothieaddreee.
`
`GNATURE OF AUTHORIzED COMPANY REPRESENTATNE
`
`TITLE
`
`
`
`Vice President, Scientific Affairs
`
`DATE
`
`06/16/98
`
`FORM FDA 3397 (99!)
`
`~~H_Wlmtw El
`
`

`

`DUSA
`
`DUSA PNAEVACEUTICALS. INC
`
`400 Cc.u-Ja‘_~s Laxus
`
`szn-ILL: NY 10595
`
`TEL 9'4 747 4300
`
`FA; 9l4 7-17 7563
`
`.‘. :L 5;=_;=-.-; ::~.-
`
`DEBARMENT CERTIFICATION
`
`DUSA Pharmaceuticals, Inc., hereby certifies that pursuant to Section 306 (k) (1)
`of the act (21 U.S.C. 335a (k) (1), we did not and will not use in any capacity the
`services of any person debarred under Subsections (a) or (b) [Section 306 (a) or
`(bll. of the EederaLEooderugaandWCosmetic (FDC) Act in connection with this
`application.
`
`//7"7Jn
`
`Stuart L. Marcus, MD, PhD
`Senior Vice President, Scientific Affairs
`And Chief Scientific Officer
`
`DUSA Pharmaceuticals. Inc.
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`

`

`DUSA
`
`DUSA PNABMACEUTICALS_ Ixc
`
`.100 CC--'»'B_E A.E\uE
`
`v.\-.-;._; NY I0595
`
`TEL 9ld 747 4300
`
`Fax 9h: 7.:7 7563
`
`'1. :_;;=..;nv:- ::-4
`
`PATENT DECLARATION
`
`The applicant, DUSA Pharmaceuticals. Inc., hereby declares to the best of its
`knowledge. with respect to the claimed indication for the subject drug, and excluding
`patents owned or licensed by the applicant:
`that there are no patents which claim the
`W" ngor the'drug'productor which claim a method of using the drug product and with
`respect to which a claim of patent infringement could reasonably be asserted if a person
`not licensed by the owner of the patent engaged in the manufacture. use. or sale of the
`drug product.
`[21 CFR § 314.53 (c)(3)]
`
`1/7.)”
`
`Stuart Marcus, MD, Ph.D.
`Senior Vice President. Scientific Affairs
`and Chief Scientific Officer
`
`DUSA Pharmaceuticals. Inc.
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`

`

`DUSA
`
`DuSA PHARMACEUTICALS. INC
`
`.100 CJLU'JEJS mixes
`
`VALHALga. NY 10595
`
`TEL 9‘4747 4300
`
`FA: 91.: 747 7563
`.‘. .'.'.‘. Cusa’xsa-J: :05-
`
`PATENT INFORMATION
`
`DUSA Pharmaceuticals. Inc. is covered by the following United States patents for
`LEVULAN® (aminolevulinic acid HCI) KERASTICK'M for Topical Solution. 20%.
`
`Expiration
`Date
`
`Patent Type
`
`Patent Owner
`
`U. 8. Patent or
`
`
`Appl. No.
`
`
`
`
` 5.211.938
`
`
`
`’ 5,422,093
`
`
`
`.71281200&e#. .Method of use
`
`5/18/2010
`
`Method of use
`
`7/28/2009
`
`. Method of use
`
`Queens University at Kingston
`exclusively assigned to DUSA
`Pharmaceuticals. Inc.
`
`Queens University at Kingston
`exclusively assigned to DUSA
`Pharmaceuticals. lnc.
`
`Queens University at Kingston
`exclusively assigned to DUSA
`
`Pharmaceuticals. Inc.
`
`
`
`
`
`
`
`
`The undersigned declares that Patent Nos. 5.079.262. 5.211.938 and 5.422.093 cover
`the method of use of the claimed indication of LEVULAN® (aminolevulinic acid HCI)
`KERASTICKTM for Topical Solution. 20%. This product is the subject of this application
`for which approval is being sought.
`[21 CFR §314.50(i)]
`
`”/{zps
`
`Stuart Marcus. MD. PhD.
`Senior Vice President, Scientific Affairs
`and Chief Scientific Officer
`DUSA Pharmaceuticals. Inc.
`
`'
`
`APPEARS ““3 WM
`0N ORIGWM-
`
`
`
`

`

`DUSA
`
`DUSA PnAnrw-ccuticzus. IN:
`
`400 Cahutaus A.£\'..5
`VA-~;L-A. NY iOSE-S
`
`TEL 9l4 747 4300
`
`FA! 9l4 7-57 7563
`I
`:.‘SA=—;:-.~; -~-.
`
`CLAIM FOR EXCLUSIVITY
`
`The applicant is claiming a period of exclusivity under 35 USC §§355(b)(j) and 21 CF R
`§314.108(b)(2). DUSA Pharmaceuticals, Inc. certifies that to the best of its knowledge
`or belief, a drug has not been previously approved under section 505(b) of the Act or 21
`CFR §314.108. containing the same active ingredient or active moiety respectively. in
`the drug for which the applicant is seeking approval.
`[21 CFR §314.50(j)(3)]
`
`4/32.;
`
`Stuart Marcus, MD. PhD.
`Senior Vice President, Scientific Affairs
`and Chief Scientific Officer
`
`DUSA Pharmaceuticals. Inc.
`
`fiEEEfiRS this WAY
`ii»: warm
`
`

`

`
`
`ORIGINAL
`~- GUIDELINES __ if
`
`INCORPORATED
`
`‘fjfj‘
`/¢~
`
`.
`
`June21,1999
`
`NEW CORRESP
`
`NC (0M
`
`'7‘
`
`Division of Dermatologic and Dental Drug Products (HFD-540)
`Office of Drug Evaluation V
`Center for Drug Evaluation and Research
`Food and Drug Administration
`.9201 Corporate Boulevard
`Rockville. MD 20850
`
`RE: Authorization Letter: NDA #20-965
`New Drug Application for Levulan® Kerastick”
`For Topical Solution Vehicle, 20%
`
`Dear Sir or Madam:
`
`On behalf of our client, DUSA Pharmaceuticals. Inc.. we hereby authorize the
`Food and Drug Administration to refer to‘the above referenced New Drug
`Application, in its entirety, on behalf of:
`
`“ DUSA Pharmaceuticals, Inc.
`400 Columbus Avenue
`
`Valhalla, New York 10595
`
`in support of any new lnvestigational New Drug applications (INDs).
`
`Please note that these files are considered CONFIDENTIAL and are not to be
`made available other than by cross-reference.
`
`Sincerely,
`
`Emma A. Lope
`
`‘ Cc: R. Carroll
`
`S. Marcus. MD, PhD
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`l0320 USA Today way. Minn-Ian FL 33025. USA . 954.433.7480 - Fax: 954432.901 s . Eémaitrgls@gate:nfl ,,
`
`

`

`EXCLUSIVITY SUMMARY FOR NDA # 20-965
`
`SUPPL #_N/A
`
`Trade Name: LEVULAN® KERAS'I'ICKTM for Topical Solution, 20%
`
`Generic Name: S-aminolevulinic acid HCl
`
`Applicant Name: DUSA Pharmaceuticals
`
`HFD # 54O
`
`Approval Date If Known:
`
`PART I: IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`1. An exclusivity determination will be made for all original applications, but only for
`certain supplements. Complete PARTS II and III ofthis Exclusivity Summary only if you
`answer "yes" to one or more of the following question about the submission.
`
`a) Is it an original NDA?
`
`YES/_X_/ 130 /_/
`
`b) Is it an effectiveness supplement?
`
`YES/
`
`/NO /_x_/
`
`If yes, what type? (SE1, SE2, etc.)
`
`c) Did it require the review ofclinical data other than to support a- safety claim or change
`in labeling related to safety? (If it required review only of bioavailability or
`bioequivalence data, answer "no.")
`
`YES /_X_/ NO I____/
`
`‘
`
`If your answer is "no" because you believe the study is a bioavailability study and,
`therefore, not eligible for exclusivity, EXPLAIN why it is a bioavailability study,
`including your reasons for disagreeing with any arguments made by the applicant that the
`study was not simply a bioavailability study.
`
`

`

`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
`m
`
`N
`
`d) Did the applicant request exclusivity?
`
`YES'/_X_/ NO /_I
`
`Ifthe answer to (d) is "yes," how many years ofexclusivity did the applicant request?
`
`Not specified by the applicant.
`
`e) Has pediatric exclusivity been granted for this Active Moiety? &
`
`IF YOU HAVEANSWEREDYLNQLTCLALL OF THE ABOVE QUESTIONS, GO
`DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. Has a product with the same active ingredient(s), dosage form, strength, route of
`administration, and dosing schedule, previously been approved by FDA for the same use?
`(Rx to OTC switches should be answered NO - please indicate as such)
`
`YES/
`
`/NO /_x_/
`
`If yes, NDA #
`
`. Drug Name
`
`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8.
`
`3. Is this drug product or indication a DESI upgrade?
`
`YES/
`
`lNO /_x_/
`
`IF THE ANSWER TO QUESTION 3 IS "YES," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8 (even if a study was required for the upgrade).
`
`

`

`PART II: FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES.
`
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 ofthe Act any drug product containing
`the same active moiety as the drug under consideration? Answer "yes" if the active
`moiety (including other esterified forms, salts, complexes, chelates or clathrates) has been
`previously approved, but this particular form ofthe active moiety, e.g., this particular
`
`If "yes,'.' identify the approved drug product(s) containing the active moiety, and, if
`known, the NDA #(s).
`
`NDA#
`
`NDA#
`
`NDA#
`
`2. Combination product.
`
`If the product contains more than one active moiety(as defined in Part II, #1), has FDA
`previously approved an application under section 505 containing any one of the active
`moieties in the drug product? If, for example, the combination contains one never-before-
`approved active moiety and one previously approved active moiety, answer "yes." (An
`active moiety that is marketed under an OTC monograph, but that was never approved
`under an NDA, is considered not previously approved.)
`
`YES/
`
`/NO/
`
`IN/A,
`
`If "yes," identifythe approved drug product(s) containing the active moiety, '
`and, if known, the NDA #(s).
`.
`
`NDA#
`
`NDA#
`
`

`

`NDA#
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II 18 "NO," GO DIRECTLY
`TO THE SIGNATURE BLOCKS ON PAGE 8. IF "YES" GO TO PART III.
`
`PART III THREE-YEAR EXCLUSIVITY FOR NDA'S AND SUPPLEMENTS.
`
`To qualify for three years of exclusivity, an application or supplement must contain
`"reports of new clinical investigations (other than bioavailability studies) essential to the
`approval of the application and conducted or sponsored by the applicant." This section
`should be completed only if the answer to PART II, Question 1 or 2 was "yes."
`
`1. Does the application contain reports'of clinical investigations?
`(The Agency interprets "clinical investigations" to mean investigations conducted on
`humans other than bioavailability studies.) If the application contains clinical
`
`investigationsW a right of reference to clinical investigations in another
`application, answer "yes," then skip to question 3(a). If the answer to 3(a) is "yes" for any
`investigation referred to in another application, do notcomplete remainder of summary
`for that investigation.
`
`YES/
`
`/NO/
`
`/
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. A clinical investigation is "essential to the approval" ifthe Agency could not have
`approved the application or supplement without relying on that investigation. Thus, the
`investigation is not essential to the approval if 1) no clinical investigation is necessary to '
`support the supplement or application in light ofpreviously approved applications (i.e.,
`information other than clinical trials, such as bioavailability data, would be sufficient to
`provide a basis for approval as an ANDA or 505(b)(2) application because of what is
`already known about a previously approvedproduct), or 2) there are published reports of
`studies (other than those conducted or sponsored by the applicant) or other publicly
`available data that independently would have been sufficient to support approval of the
`application, without reference to the clinical investigation submitted in the application.
`
`(a) In light of previously approved applications, is a clinical investigation (either
`conducted by the applicant or available from some other source, including the published
`literature) necessary to support approval of the application or Supplement?
`
`

`

`YES/
`
`/NO/
`
`/
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary for
`approval AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`(b) Did the applicant submit a list ofpublished studies relevant to the safety and
`effectiveness ofthis drug product and a statement that the publicly available data would
`not independently support approval of the application?
`
`YES/
`
`/NO/
`
`/
`
`(1) If the answer to 2(b) is "yes," do you personally know
`of any reason to disagree with the applicant's conclusion? If not applicable, answer NO.
`
`YES/
`
`/NO/
`
`/
`
`7
`
`,If yes, explaim,i,,,_,,, ,7
`
`YES/
`
`/NO/
`
`/
`
`If yes, explain:
`
`(c) Ifthe answers to (b)(l) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`Studies comparing two products with the same ingredient(s) are considered to be
`bioavailability studies for the purpose of this section.
`
`

`

`3. In addition to being essential, investigations must be "new" to support exclusivity. The
`agency interprets "new clinical investigation" to mean an investigation that 1) has not
`been relied on by the agency to demonstrate the effectiveness of a previously approved
`drug for any indication and 2) does not duplicate the results of another investigation that
`was relied on by the agency to demonstrate the effectiveness of a previously approved
`drug product, i.e., does not redemonstrate something the agency considers to have been
`demonstrated in an already approved application.— —
`_
`
`a) For each investigation identified as "essential to the approval," has the investigation
`been relied on by the agency to demonstrate the effectiveness of a previously approved
`drug product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
`
`Investigation #1 YES /‘__/ NO _/
`
`Investigation #2 YES/
`
`
`INo)
`
`/“
`
`If you have answered "yes" for one or more investigations, identify
`each such investigation and the NDA in which each was relied upon:
`
`
`
`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support
`the effectiveness of a previously approvedidrug product?
`
`Investigation #1 YES/
`
`/NO/
`
`' Investigation #2 YES/
`
`INOI
`
`/
`
`/
`
`If you have answered "yes" for one or more investigation, identify
`the NDA in which a similar investigation was relied on:
`
`
`
`
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the
`application or supplement that is essential to the approval (i.e., the investigations listed in
`#2(c), less any that are not "new"):
`
`

`

`K
`
`
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must
`also have been conducted or sponsored by the applicant An investigation was "conducted
`or sponsored by" the applicant if, before or during the conduct ofthe investigation, 1) the
`applicant was the sponsor ofthe IND named in the form FDA 1571 filed with the
`Agency, or 2) the applicant (or its predecessor in interest) provided substantial support for
`the' study. Ordinarily, substantial support will mean providing 50 percent or more of the
`cost of the study.
`
`a) For each investigation identified in response to question 3(c): ifthe investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`Investigation #1
`
`IND #
`YES /_._/ NO /__/ Explain:
`
`Investigation #2
`
`IND #
`
`YES /_/ NO /_I Explain:
`
`(b) For each investigation not carried out under an 1ND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
`
`Investigation #1
`
`YES /___/ Explain
`
`NO /_/ Explain
`
`
`
`
`
`Investigation #2
`
`YES/
`
`lExplain
`
`NO /_/ Explain
`
`

`

`
`
`
`
`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe
`that the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to
`the drug are purchased (not just studies on the drug), the applicant may be considered to
`have sponsored or conducted the studies sponsored or conducted by its predecessor in
`interest.)
`
`YES/
`
`INO/
`
`/
`
`If yes, explain:
`
`
`
`A
`
`Signature ofOffice/Division Director:
`/S/
`i <6 l 1/?7
`SignaturezDate: “I#111?
`
`cc: Original NDA 20-965; RFD-540 Division File
`
`RFD-93 Mary Ann Holovac
`
`APPEARS THIS WAY
`
`ON ORIGINAL
`
`

`

`PEDIATRIC PAGE
`(Complete for all original applications and all efficacy supplements)
`NOTE: A new Pediatric Page must be completed at the time of each action even though one was prepared at the time of the last action.
`MUM Supplement!
`Circle one: ear
`s22 sea SE4 555 see
`
`HEW Trade and generic namesldosage form:
`$11.04
`Applicant flm '
`Therapeutic Class
`
`/ S
`
`Action:@AE NA
`
`/ 920é
`
`Indicationlsl previously approved
`Perfiatric information in labeling of approved indicationlsl is adequate _ inadequate _.
`Proposed indication in this applicatiokfii fido
`
`W M m
`M
`
`FOR SUPPLEMENTS. ANSWER THE FOLLOWING QUESTIONS IN RELATION TO THE PROPOSED INDICATION.
`IS THE DRUG NEEDED IN ANY PEDIATRIC AGE GROUPS? ___Yes IContirtue with questions) _No (Sign and return the form)
`WHAT PEDIATRIC AGE GROUPS IS THE DRUG NEEDED?
`ICheclt all that apply)
`_Neonates lBirth-Imonthl _lnfants llmonth-Zyrsl _Children (2-12yrs) _Ado|eoentsl12-16yrsl
`
`_ I. PEDIATRIC LABELING IS ADEDUATE FDR ALI. PEDIATRIC AGE GROUPS. Appropriate information has been submitted in this or previous
`applications and has been adequately summarized in the labeling to permit satisfactory labeling for all pediatric age groups. Further information is not
`required.
`
`_ 2. PEDIATRIC LABELING IS ADEDUATE FDR CEBIALN AGE GROUPS. Appropriate information has been submitted in this or previous applications and
`has been adequately summarized in the labeling to permit satisfactory labeling for certain pediatric age groups le.g.. infants, children, and adolescents
`but not neonates). Further information is not required.
`
`_ 3. PEDIATRIC STUDIES ARE NEEDED. There is potential for use in children, and further information is required to pennit adequate labeling for this use.
`
`_ a. A new dosing formulation is needed, and applicant has agreed to provide the appropriate formulation.
`
`__ b. A new dosing formulation is needed, however the sponsor is either not willing to provide it or is in negotiations with FDA.
`
`__ c. The applicant has cormnitted to doing such studies as will be required.
`_ ll) Studies are ongoing.
`_ (2) Protocols were submitted and approved.
`_ (3) Protocols were submitted and are under review.
`_ )4) If no protocol has been submitted. attach memo describing status of discussions.
`
`_ d.
`
`If the sponsor is not wilfing to do pediatric stutfies. attach copies of FDA's written request that such studies be done and of the sponsor's
`written response to that request.
`
`_ 4. PEDIATRIC STUDIES ARE NOT NEEDED. The druglbiologic product has little potential for use in pediatric patients. Attach memo explaining why
`perfiatric studies are not needed.
`'
`
`_ 5.
`
`If none of the above apply, attach an explanation. as necessary.
`
`ARE THERE ANY PEDIATRIC PHASE IV COMMITMENTS IN THE ACTION LETTER? __Yes
`ATTACH AN EXPLANATION FOR ANY OF THE FOREGOING ITEMS. AS NECESSAR .
`
`_x_No
`
` cit; ore of Preparer and Title
`
`
`
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`

`

`The principal risk factors for the development of actinic keratoses are skin
`type and cumulative sun exposure over many years. The age group most
`commonly affected are 60 years old and older. Prevalence of actinic
`keratoses is extremely low in the pediatric population. Therefore, pediatric
`studies are not warranted.
`
`J4“
`
`
`
`APPEARS THIS WAY
`
`0" ORIGINAL
`
`

`

`
`
`6 DEPARTMENTOFHEALTH&HUMANSERVICES
`
`i
`
`23/
`
`m Llfil’m
`PublicHealthService
`
`Rockville MD 20857
`
`NDA 20-965
`
`JUL 2 A 1998
`
`DUSA Pharmaceuticals, Inc.
`Attention: Stuart L. Marcus, MD, Ph.D.
`400 Columbus Avenue
`
`Valhalla, NY 10595
`
`Dear Dr. Stuart:
`
`We have received your new drug application (NDA) submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act for the following:
`
`Name of Drug Product: Levulan Kerastick (aminolevulinic acid ) for Topical Solution , 20%
`
`,Ihstapeutic Classification;Standards;
`
`Date of Application: June 29, 1998
`
`Date of Receipt: July 1, 1998
`
`Our Reference Number: 20-965
`
`Unless we notify you within 60 days of our receipt date that the application is not sufiiciently
`complete to permit a substantive review, this application will be filed under section 505(b) of the
`Act on August 30, 1998 in accordance with 21 CPR 314.101(a). If the application is filed, the
`user fee goal date will be July 1, 1999.
`
`Under 21 CPR 3 14. 102(c)'of the new drug regulations, you may request an informal conference
`with this Division (to be held approximately 90 days from the above receipt date) for a brief
`report on the status of the review but not on the application's ultimate approvability.
`Alternatively, you may choose to receive such a report by telephone.
`
`Please cite the NDA number listed above at the top of the first page of any communications
`concerning this application.
`
`APPEARS THIS WAY
`
`0N ORIGINAL
`
`

`

`NDA 20-965
`
`Page 2
`
`If you have any questions, contact Olga Cintron, Project Manager, at (301) 827-2020.
`
`Sincerely,
`
` 7/« 12/7!”
`
`Mary Jean Kozma-Fomaro
`Supervisor, Project Management Staff
`Division of Dermatologic and Dental Drug Products
`Office of Drug Evaluation V
`Center for Drug Evaluation and Research
`
`cc:
`
`Archival NDA 20-965
`
`HFD-540/Div. Files
`
`HFD-540/O.Cintron
`
`S.Walker
`
`7 A.Jacobs
`- W.DeCamp
`DISTRICT OFFICE
`
`Drafted by: smc/July 23, 1998
`Initialed by:
`final:
`
`filename: 2096SACK
`
`ACKNOWLEDGEMENT (AC)
`
`‘
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`

`

`ATTACHMENT TO FORM FDA 356h
`
`ESTABLISHMENT INFORMATION:
`
`Drug Substance
`
`I
`
`The drug substance will be manufactured. packaged. controlled and shipped by
`Ithe drug substanc
`anufacturer.
`Stability studies of the drug
`substance will be conducted MI
`I
`Name and Address of Manufacturing Site: NW
`
`Establishment Registration No.:
`
`Not Applicable
`
`Contact Person and Phone No.:
`
`
`
`Site Inspection by FDA:
`
`Drug Product
`
`The facility is ready for
`inspection.
`
`labeled. controlled and
`The drug product will be manufactured, packaged,
`shipped by North Safety Products. the drug product manufacturer. North Safety
`Products will be responsible for the manufacture of the bulk solution vehicle.
`filling and sealing of the glass ampules and assembly of the Levulan Kerastick.
`North Safety Products is responsible for the in-process testing of the bulk
`Levulan Topical Solution Vehicle.-
`
`Name and Address of the Manufacturing Site:
`
`North Safety Products
`2000 Plainfield Pike
`
`Cranston. RI 02921
`
`Establishment Registration No.:
`
`#1217998
`
`Contact Person and Phone No.:
`
`.
`
`Jonny Smith '
`Manager, Business Quality
`(401 )-946-4400
`
`

`

`Site Inspection by FDA:
`
`This facility is ready for inspection.
`
`The raw materials, process intermediates and finished products are analyzed by
`a contract analytical laboratory. The finished product stability studies are also
`conducted by the contract laboratory listed below:
`
`Guidelines Analytical Laboratories, Inc. (GAL)
`10320 USA Today WAY
`Miramar, FL 33025
`DMF No.::
`
`Establishment Registration No.:
`
`Contact Person and Phone No.:
`
`#1052961
`
`Mike Ray
`President
`
`(954)-433-7480
`
`Site Inspection by FDA:
`
`This facility is ready for inspection.
`
`CROSS REFERENCES:
`
`r—‘——-“/
`DUSA‘s IND for Aminolevulinic AcidHCI:—»~ mm
`\ GAL's DMF:
`DMF-i
`l,
`DM
`l
`DM
`1
`DM
`
`MF:
`MF:
`
`MF:
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`