`
`APPLICATION NUMBER: 20-965
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
`REVIEW FOR HFD-54O
`OFFICE OF NEW DRUG CHEMISTRY
`MICROBIOLOGY STAFF
`MICROBIOLOGIST’S REVIEW #1 OF‘AMMENDMENT
`
`June 3, 1999
`
`A.
`
`l. NDA
`
`20-965 Amendment
`
`SPONSOR
`
`DUSA Pharmaceuticals
`400 Columbus Avenue
`Valhalla, NY 10595
`
`2.
`
`PRODUCT NAMES: Levulan°, (aminolevulinic acid HCl) I‘ierastikTM for Topical
`Solution 20%
`V
`
`3. DOSAGE FORM AND ROUTE OF ADMINISTRATION: 20% Topical SolutionM
`
`4. METHODgsz OF STERILIZATION; na
`
`5.
`
`PHARMACOLOGICAL CATEGORY: Photosensitizer
`
`6. DRUG PRIORITY CLASSIFICATION:
`._-. :_.
`- ————__—m
`
`B'
`
`1' DATE OF “WSWMEQNWREH597*“
`
`2. DATE OF AMENDMENT: June _2, 1999
`
`3. RELATED DOCUMENTS:
`
`4. ASSIGNED FOR REVIEW: na
`
`c. REMARKS: This review addresses the microbial limit sbecincaridris er the drug product.
`The amendment was faxed to the Agency, with the hard copy to follow.
`.. .-.
`
`._,_ _ 7.. VH_.
`
`APPEARS THIS'WAY.
`0" ORIGINAL
`
`
`
`NDA 20-965 Amendment
`
`'
`
`Microbiologist's Review # l
`:54,
`
`D. CONCLUSIONS: This application is recommended for approval on the basis of product
`quality microbiology.
`—
`
`
`
`CC:
`
`HFD 540/Consult File
`
`HFD 540/0. Cintron
`
`HFD 540/Rev Chemist
`
`HFD SOS/Consult File
`HFD 805/8. Riley
`
`Drafted by: B. Riley, 6/3/99
`R/D initialed by: P. Cooney,
`
`APPEARS THIS WAY
`
`: ""“0N—»0RIGlNAL—‘f—=—l ..M---
`
`Page 2
`
`
`
`3 H m I—mcum y
`
`APP. 30 "‘1‘?
`
`REVIEW FOR HFD-54O
`
`OFFICE OF NEW DRUG CHEMISTRY
`
`MICROBIOLOGY STAFF
`
`MICROBIOLOGIST'S REVIEW # 1 OF NDA
`
`April 20, 1999
`
`A.
`
`l . NDA
`
`20—965
`
`SPONSOR
`
`DUSA Pharmaceuticals
`
`400 Columbus Avenue
`
`Valhalla, NY 10595
`
`IQ
`
`PRODUCT NAMES: Levulan®, (arninolevulinic acid HC1)KerastikT-“ for Topical
`Solution 20%
`
`3. DOSAGE FORM AND ROUTE OF ADMINISTRATION: 20% Topical Solution in a
`:.-:WL~_7LN : :KerasticlflApplicamr , C
`
`4. METHODIST OF STERILIZATION: N/A
`
`5.
`
`PHARMACOLOGICAL CATEGORY: Photosensitizer
`
`6. DRUG PRIORITY CLASSIFICATION:
`
`B.
`
`1. DATE OF INITIAL SUBMISSION: June 29. 1998
`
`2. DATE OF AMENDMENT:
`
`3.
`
`RELATED DOCUMENTS:
`
`4. ASSIGNED FOR REVIEW: April I, 1999
`C. REMARKS: Theng product (Levulan Kerastick) is a two component applicator in which
`Levulan and the Topical Solution Vehicle are admixed immediately prior to administration.
`- This review addresses the validation of the Microbial Limit Test for this non-sterile topical
`
`product.
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`
`
`MicrobiolOgist's Review # 1
`'
`NDA 20-965
`
`
`D. CONCLUSIONS: This application is approvable, pending resolution of microbiological
`deficiencies. Please see “Microbiologists List of Deficiencies”.
`
`
`
`cc:
`
`HFD 540/Consult File
`
`l-IFD 540/0. Cintron
`
`HFD 540/Rev Chemist
`
`HFD 805/Consult File
`
`HFD 805/8. Riley
`
`Drafted by: B. Riley, 4/20/99
`R/D initialed by: P. Cooney,
`
`APPEARS THIS WAY
`ON ORIGINAL
`
`
`
`
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