`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`202324Orig1s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`
`06 January 2012
`
`
`
`
`
`
`202-324/N000
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`INLYTA
`
`Non-proprietary: Axitinib
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`21 December 2011 (SD 24)
`22 December 2011
`NA
`
`Submission History (for amendments only) –
`Submit Date(s)
`Microbiology Review #
`14 April 2011
`1
`
`2
`
`Assigned to Reviewer
`NA
`
`Review Date(s)
`12 December 2011
`
`Pfizer, Inc.
`10646 Science enter Drive
`San Diego CA 92121
`Alison Russell, Worldwide Regulatory Strategy
`(858) 622-3234
`
`Denise A. Miller
`
`Approve
`
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`
`
`
`
`Representative:
`Telephone:
`
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`
`Reference ID: 3068657
`
`
`
`NDA 202-324/N000
`
`
`
`
`
`
`Microbiology Review # 2
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION: Original New Drug Application
`
`2.
`
`SUBMISSION PROVIDES FOR: The manufacture of a tablet drug
`product.
`
`MANUFACTURING SITE:
`
`Pfizer Manufacturing Deutcshland GmbH
`Betriebsstatte Freiburg
`Mooswaldallee 1
`79090 Freiburg Germany
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`(cid:190) Tablet
`(cid:190) Oral, Immediate Release
`(cid:190) 1 and 5 mg /tablet
`
`METHOD(S) OF STERILIZATION: not sterile
`
`3.
`
`
`
`
`
`
`4.
`
`
`5.
`
`6.
`
`
`A.
`
`B.
`
`PHARMACOLOGICAL CATEGORY: tyrosine kinase inhibitor used
`for the treatment for advanced renal cell carcinoma
`
`
`SUPPORTING/RELATED DOCUMENTS: NA
`
`REMARKS:
`1) Application is in e-CTD format.
`
`C.
`
`
`
`
`filename: N202324N000R2.doc
`
`
`
`
`
`Reference ID: 3068657
`
`
`
`Page 2 of 4
`
`
`
`
`
`
`
`
`Microbiology Review # 2
`
`
`NDA 202-324/N000
`
`Executive Summary
`
`
`Recommendations
`
`A.
`
`I.
`
`II.
`
`
`Recommendation on Approvability – The recommendation is to
`approve this submission from a quality microbiology standpoint.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable - NA
`
`
`Summary of Microbiology Assessments
`
`
`B.
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology – Formulated powders are
`
` film coated and packaged. This is a non-
`
`sterile drug product.
`
`Brief Description of Microbiology Deficiencies – None
`
`Assessment of Risk Due to Microbiology Deficiencies – NA
`
`
`B.
`
`C.
`
`III. Administrative
`
`
`A.
`
`
`
`B.
`
`
`C.
`
`Reviewer's Signature _____________________________
`
`
`
`Denise A. Miller
`Microbiologist, NDMS
`
`Endorsement Block ______________________________
`
`
`
`Stephen E. Langille
`Senior Microbiologist, NDMS
`
`CC Block
`N/A
`
`
`
`
`
`Reference ID: 3068657
`
`
`
`Page 3 of 4
`
`
`
`1 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/
`----------------------------------------------------
`
`DENISE A MILLER
`01/09/2012
`
`STEPHEN E LANGILLE
`01/09/2012
`
`Reference ID: 3068657
`
`
`
`Product Quality Microbiology Review
`
`12 December 2011
`
`
`
`
`
`
`202-324/N000
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`INLYTA
`
`Non-proprietary: Axitinib
`
`1
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`14 April 2011
`14 April 2011
`17 May 2011
`28 October 2011
`28 October 2011
`NA
`
`Assigned to Reviewer
`17 May 2011
`NA
`
`
`Submission History (for amendments only) – NA
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`
`
`
`
`Representative:
`Telephone:
`
`
`Pfizer, Inc.
`10646 Science enter Drive
`San Diego CA 92121
`Alison Russell, Worldwide Regulatory Strategy
`(858) 622-3234
`
`Denise A. Miller
`
`Approvable pending resolution of quality
`microbiological deficiencies listed on page 9.
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`Reference ID: 3057117
`
`
`
`NDA 202-324/N000
`
`
`
`
`
`
`Microbiology Review # 1
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION: Original New Drug Application
`
`2.
`
`SUBMISSION PROVIDES FOR: The manufacture of a tablet drug
`product.
`
`MANUFACTURING SITE:
`
`Pfizer Manufacturing Deutcshland GmbH
`Betriebsstatte Freiburg
`Mooswaldallee 1
`79090 Freiburg Germany
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`(cid:190) Tablet
`(cid:190) Oral, Immediate Release
`(cid:190) 1 and 5 mg /tablet
`
`METHOD(S) OF STERILIZATION: not sterile
`
`3.
`
`
`
`
`
`
`4.
`
`
`5.
`
`6.
`
`
`A.
`
`B.
`
`C.
`
`
`
`
`
`PHARMACOLOGICAL CATEGORY: tyrosine kinase inhibitor used
`for the treatment for advanced renal cell carcinoma
`
`
`SUPPORTING/RELATED DOCUMENTS: NA
`
`REMARKS:
`1) Application is in e-CTD format.
`2) Consult requested evaluation of Pfizer’s request exclude microbial limit testing
`as a release test. The testing was also excluded in the stability program.
`3) Information request #1 was sent on 26 September 2011. A response was
`received on 28 October 2011.
`
`
`
`filename: N202324N000R1.doc
`
`
`
`
`
`Reference ID: 3057117
`
`
`
`Page 2 of 9
`
`
`
`
`
`
`
`
`Microbiology Review # 1
`
`
`NDA 202-324/N000
`
`Executive Summary
`
`
`Recommendations
`
`A.
`
`Recommendation on Approvability - This submission is
`approvable pending resolution of microbiological deficiencies.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable - NA
`
`
`Summary of Microbiology Assessments
`
`I.
`
`II.
`
`
`
`B.
`
`A.
`
`
`B.
`
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology – Formulated powders are
`
` film coated and packaged. This is a non-
`
`sterile drug product.
`
`Brief Description of Microbiology Deficiencies – Lack of
`microbial testing on the final product for either release or stability
`was not sufficiently justified.
`
`Assessment of Risk Due to Microbiology Deficiencies – There is
`a small risk to the patient to ingest contaminated product as a result
`of the deficiencies.
`
`
`III. Administrative
`
`
`A.
`
`
`
`B.
`
`
`C.
`
`Reviewer's Signature _____________________________
`
`
`
`Denise A. Miller
`Microbiologist, NDMS
`
`Endorsement Block ______________________________
`
`
`
`Bryan S. Riley,
`Senior Microbiologist, NDMS
`
`CC Block
`N/A
`
`
`
`
`
`Reference ID: 3057117
`
`
`
`Page 3 of 9
`
`
`
`6 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/
`----------------------------------------------------
`
`DENISE A MILLER
`12/12/2011
`
`BRYAN S RILEY
`12/13/2011
`I concur.
`
`Reference ID: 3057117
`
`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`
`TO (Division/Office): New Drug Microbiology Staff
`
` Email to: CDER OPS IO MICRO
` Mail to: WO Bldg 51, Room 4193
`
`
`
`REQUEST DATE
`IND NO.
`NDA NO.
`202324
`5/17/2011
`
`
`NAMES OF DRUG
`axitinib
`
`
`PRIORITY CONSIDERATION
`standard
`
`CMC MICROBIOLOGY AND STERILITY ASSURANCE
`REVIEW REQUEST
`
`FROM: Don Henry
`
`
`PROJECT MANAGER (if other than sender):
`
`
`TYPE OF DOCUMENT
`DATE OF DOCUMENT
`Original NDA submission
`4/14/2011
`
`
`PDUFA DATE
`DESIRED COMPLETION DATE
`February 14, 2012
`September 14, 2011
`
`NAME OF APPLICANT OR SPONSOR: Pfizer
`
`
`
`
`
`
` 30-DAY SAFETY REVIEW NEEDED
`
` NDA FILING REVIEW NEEDED BY:
`
`
`
` BUNDLED
`
` (cid:134)
`
` (cid:134)
`
` (cid:134)
`
`GENERAL PROVISIONS IN APPLICATION
`
`
`
`
`
`
` (cid:134) CBE-0 SUPPLEMENT
`
` (cid:134) CBE-30 SUPPLEMENT
`
` (cid:134) CHANGE IN DOSAGE, STRENGTH / POTENCY
`
`
`
`
` (cid:132)
`
` DOCUMENT IN EDR
`
`
`
`
`COMMENTS / SPECIAL INSTRUCTIONS:
`
`
`
`This is a NME. For this solid oral tablet, the sponsor has provided justification for not including the
`microbial limits testing as part of the specification.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`SIGNATURE OF REQUESTER
`
`
`Don L. Henry
`
`
`REVIEW REQUEST DELIVERED BY (Check one):
`
` (cid:134) DARRTS (cid:134) EDR (cid:132) E-MAIL (cid:134) MAIL (cid:134) HAND
`
`DOCUMENTS FOR REVIEW DELIVERED BY (Check one):
`
` (cid:134) EDR (cid:132) E-MAIL (cid:134) MAIL (cid:134) HAND
`
`Reference ID: 2948110
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`DON L HENRY
`05/17/2011
`
`Reference ID: 2948110
`
`
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