`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`203441Orig1s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
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`
`
`

`

`Product Quality Microbiology Review
`
`29 MARCH 2012
`
`
`
`NDA: 203441/N-001
`
`Drug Product Name
`Proprietary: GATTEX
`Non-proprietary: Teduglutide [rDNA origin] powder for sc injection
`
`
`Review Number: 1
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`16 August 2011
`16 August 2011
`28 December 2011
`30 November 2011
`30 November 2011
`28 December 2011
`
`Assigned to Reviewer
`5 January 2012
`5 January 2012
`
`
`
`Submission History (for amendments only): N/A
`
`Applicant/Sponsor
`Name: NPS Pharmaceuticals
`Address: 550 Hills Drive, 3rd Floor, Bedminster, NJ 07921
`Representative: Sandra C. Cottrell, MA, Ph.D.
`Telephone: 908-450-5300
`
`
`Name of Reviewer: Bryan S. Riley, Ph.D.
`
`Conclusion: Recommended for Approval
`
`
`Reference ID: 3109358
`
`

`

`NDA 203441 (GATTEX)
`
`Microbiology Review #1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`3.
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`4.
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`5.
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`6.
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`TYPE OF SUBMISSION: 505(b)(1) original NDA
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`SUBMISSION PROVIDES FOR: A sterile parenteral drug product
`
`MANUFACTURING SITE:
`
`Hospira, Inc.
`1776 N. Centennial Drive
`
`McPherson, KS 67460
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: Sterile lyophilized powder in a glass vial for
`subcutaneous injection, 10 mg/mL.
`
`METHOD(S) OF STERILIZATION:
`
`(”"0
`
`PHARMACOLOGICAL CATEGORY: Treatment of Adults with Short
`
`Bowel Syndrome (SBS)
`
`B.
`
`SUPPORTING/RELATED DOCUMENTS: DMF
`
`“M”
`
`C.
`
`REMARKS: This was an eCTD submission.
`
`filename: N203441R1.doc
`
`Reference ID: 31 09358
`
`Page 2 ofll
`
`

`

`
`
`
`Microbiology Review #1
`
`
`NDA 203441 (GATTEX)
`
`Executive Summary
`
`
`Recommendations
`
`A.
`
`I.
`
`II.
`
`
`Recommendation on Approvability – This submission is
`recommended for approval on the basis of product quality
`microbiology.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable – N/A
`
`
`Summary of Microbiology Assessments
`
`
`B.
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology – The drug product is sterile
` and lyophilized.
`
`Brief Description of Microbiology Deficiencies – N/A
`
`Assessment of Risk Due to Microbiology Deficiencies – N/A
`
`
`B.
`
`C.
`
`III. Administrative
`
`
`A.
`
`
`B.
`
`
`C.
`
`Reviewer's Signature _____________________________
`Bryan S. Riley, Ph.D.
`Senior Review Microbiologist, OPS/NDMS
`
`
`
`Endorsement Block ______________________________
`John W. Metcalfe, Ph.D.
`Senior Review Microbiologist, OPS/NDMS
`
`CC Block
`N/A
`
`
`
`
`
`Reference ID: 3109358
`
`
`
`Page 3 of 11
`
`
`
`8 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`(b) (4)
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BRYAN S RILEY
`03/30/2012
`
`JOHN W METCALFE
`03/30/2012
`I concur.
`
`Reference ID: 3109358
`
`

`

`PRODUCT QUALITY MICROBIOLOGY FILING CHECKLIST
`NDA Number: 203441
`Applicant: NPS
`Letter Date: 30 NOV 2011
`Pharmaceuticals, Inc.
`and 16 AUG 2011
`Stamp Date: 30 NOV 2011 and
`16 AUG 2011
`
`Drug Name: GATTEX
`
`NDA Type: 505(b)(1)
`
`
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`
`
` X
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` X
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` X
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` X
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` X
`
`X
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` X
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` X
`
`
`1
`
`Comments
`The submission is in
`the eCTD format.
`
`
`
`
`
`
`
`CCI studies were
`provided; AME test
`N/A
`
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`
`10 January 2012
`Date
`
`Date
`
`Reference ID: 3070038
`
`
`The following are necessary to initiate a review of the NDA application:
`Content Parameter
`Yes No
`
`Is the product quality microbiology information described
`in the NDA and organized in a manner to allow substantive
`review to begin? Is it legible, indexed, and/or paginated
`adequately?
`
`2 Has the applicant submitted an overall description of the
`manufacturing processes and microbiological controls used
`in the manufacture of the drug product?
`3 Has the applicant submitted protocols and results of
`validation studies concerning microbiological control
`processes used in the manufacture of the drug product?
`4 Are any study reports or published articles in a foreign
`language? If yes, has the translated version been included
`in the submission for review?
`5 Has the applicant submitted preservative effectiveness
`studies (if applicable) and container-closure integrity
`studies?
`6 Has the applicant submitted microbiological specifications
`for the drug product and a description of the test methods?
`7 Has the applicant submitted the results of analytical method
`verification studies?
`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
`
`
`
`9
`
`Additional Comments: This is a rolling submission. The CMC section was submitted on 16
`August 2011 and the remainder of the NDA was submitted on 30 November 2011.
`
`
`
`
`
`
`Bryan S. Riley, Ph.D.
`Senior Review Microbiologist
`
`John W. Metcalfe, Ph.D.
`Senior Review Microbiologist
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BRYAN S RILEY
`01/11/2012
`
`JOHN W METCALFE
`01/11/2012
`I concur.
`
`Reference ID: 3070038
`
`