CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-341
`
`MICROBIOLOGY REVIEW! S)
`
`

`

`Product Quality Microbiology Review
`
`4 MARCH 2009
`
`NBA: 22-341
`
`Drug Product Name
`Proprietary: Victoza
`Non-proprietary: liraglutide
`Drug Product Priority Classification: S
`
`Review Number: 1
`
`Dates of Submission(s) Covered by this Review
`Review
`Request
`6/5/2008
`
`.
`.
`Assrgned to Rev1ewer
`6/9/2008
`
`Letter
`5/23/2008
`
`Stamp
`5/23/2008
`
`Submission History (for amendments only): N/A
`
`Applicant/Sponsor
`Name: Novo Nordisk Inc.
`
`Address: 100 College Road West, Princeton, NJ 08540
`Representative: Mary Ann McElligott
`Telephone: 609—987-5 831
`
`Name of Reviewer: Bryan S. Riley, Ph.D.
`
`Conclusion: Recommended for Approval
`
`

`

`NDA 22—341 (Victoza)
`
`Microbiology Review #1
`
`A.
`
`B.
`
`C.
`
`Product Quality Microbiology Data Sheet
`
`1.
`
`2.
`
`5.
`
`6.
`
`TYPE OF SUBMISSION: Original NDA 505(b)(1)
`
`SUBMISSION PROVIDES FOR: A sterile parenteral drug product
`
`MANUFACTURING SITE: Novo Nordisk
`
`Bagsvaerd, Denmark
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`
`. STRENGTH/POTENCY: Sterile preserved aqueous solution in a 3 mL
`glass pen-fill cartridge for SC injection, 6 mg/mL.
`
`METHOD(S) OF STERILIZATION:
`
`
`
`Fill
`
`PHARMACOLOGICAL CATEGORY: Control of Type 2 Diabetes.
`
`SUPPORTING/RELATED DOCUMENTS: DMFs 21494 and M
`
`REMARKS: This was an eCTD submission. An IQA was performed by ONDQA
`(dated 7/2/2008). The majority of the sterility assurance information was provided
`in Type V DMF 21494 (Novo Nordisk). The submission also contained a
`Comparability Protocol for the Addition of Clayton, NC as an additional
`manufacturing site (see Section R. Regional Information).
`
`m4)
`
`m4)
`
`filename: N022341R1.doc
`
`Page 2 of 8
`
`

`

`Microbiology Review #1
`NDA 22—341 (Victoza)
`
`
`Executive Summary
`
`1.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability — This submission is
`recommended for approval on the basis of product quality
`microbiology.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable — N/A
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology — The drug product is sterile
`-,__——————————*
`filled.
`
`m4)
`
`Brief Description of Microbiology Deficiencies — N/A
`
`Assessment of Risk Due to Microbiology Deficiencies — N/A
`
`III.
`
`Administrative
`
`A.
`
`Reviewer's Signature
`
`
`
`Bryan S. Riley, PhD.
`
`B.
`
`Endorsement Block
`
`
`
`James L. McVey
`Microbiology Team Leader
`
`C.
`
`CC Block
`N/A
`
`_—____—_—_————_—-——-—-—
`
`Page 3 of8
`
`

`

`5
`
`Page(s) Withheld
`
`\/
`
`Trade Secret / Confidential (b4)
`
`Draft Labeling (b4)
`
`Draft Labeling (b5)
`
`Deliberative Process (b5)
`
`Withheld Track Number: Microbiology-
`
`1
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Bryan Riley .
`3/5/2009 01:01:27 PM
`MICROBIOLOGIST
`
`James MCVey
`3/10/2009 10:50:47 AM
`MICROBIOLOGIST
`I concur.
`
`

`

`PRODUCT QUALITY MICROBIOLOGY FILING CHECKLIST
`Letter Date: 5/23/2008
`
`Applicant: Novo Nordisk Inc
`
`NDA Number: 22-341
`Drug Name: Victoza
`
`NDA Type: 505(b)(1)
`
`Stamp Date: 5/23/2008
`
`+
`
`The following are necessary to initiate a review of the NDA application:
`
`
`Content Parameter
`Yes_TI_ No
`Comments
`
`
`Is the product quality microbiology information described
`Information provided
`1
`in the NDA and organized in a manner to allow substantive X
`m the NDA and in
`
`review to begin? Is it legible, indexed, and/or paginated
`DMF 21494
`
`
`'I
`.
`.
`adequately?
`
`
`Has the applicant submitted an overall description ofthe
`2
`Information PYOYlded
`
`manufacturing processes and microbiological controls used X
`in the NDA and in
`
`in the manufacture ofthe drugproduct?
`DMF 21494
`
`
`
`Has the applicant submitted protocols and results of
`Information provided
`3
`
`validation studies concerning microbiological control
`In DMF 21494
`X
`
`processes used in the manufacture of the drug product?
`
`4
`Are any study reports or published articles in a foreign
`
`language? Ifyes, has the translated version been included
`X
`in the submission for review?
`_.
`
`5
`Has the applicant submitted preservative effectiveness
`Information provided
`
`studies (if applicable) and container-closure integrity
`in the NDA and in
`X
`studies?
`DMF 21494
`
`+
`6
`Has the applicantsubmittedmicrobiological specifications
`Informationprovided
`
`
`
`for the drug product and a description ofthe test methods?
`X
`in the NDA and in
`
`+
`DMF 21494
`
`7
`Has the applicant submitted the results of analytical method
`Information provided
`verification studies?
`X
`1n DMF 21494
`
`
`8
`Has the applicant submitted all special/critical studies/data
`requested during pre-submission meetings and/or
`discussions?
`
`
`
`
` Is this NDA fileable? If not, then describe why. ,
`
`
`X
`
`t
`
`Additional Comments: The application includes a Comparability Protocol for an additional
`manufacturing site for the drug product (Novo Nordisk, Clayton, NC, USA).
`
`23 June 2008
`
`//Date ‘
`Bryan S. Riley, Ph.D.
`Senior Review Microbiologist, OPS/NDMS
`
`//Date
`James L. McVey
`OPS/NDMS Team Leader
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Bryan Riley
`6/23/2008 11:30:42 AM
`MICROBIOLOGIST
`
`James McVey
`6/23/2008 01:54:22 PM
`MICROBIOLOGIST
`I concur
`
`