`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`202570Orig1s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`
`1 August 2011
`
`
`
`
`
`
`202-570
`
`
`
`
`
`
`
`
`
`
`NDA:
`
`
`Drug Product Name
`Proprietary:
`Crizotinib
`
`Non-proprietary: PF -02341066
`
`1
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`30 March 2011
`30 March 2011
`5 May 2011
`27 July 2011
`27 July 2011
`N/A
`
`Assigned to Reviewer
`11 May 2011
`N/A
`
`
`Submission History (for amendments only): N/A
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`
`
`
`
`
`Representative:
`Telephone:
`
`
`
`Pfizer Inc.
`10646 Science Center Drive
`San Diego, CA 92121
`
`Ron Domingo
`858-622-3234
`
`Stephen E. Langille, Ph.D.
`
`Recommended for approval
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`
`Reference ID: 2982022
`
`
`
`
`
`
`
`
`Microbiology Review # 1
`
`
`NDA 202-
`
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION:
`
`Original NDA
`
`2.
`
`
`SUBMISSION PROVIDES FOR:
`The manufacture of a solid
`
`
`
`
`
` oral drug product.
`
`MANUFACTURING SITE:
`
`
`
`
`Pfizer Manufacturing
`Deutschland GmbH
`Betriebsstätte Freiburg,
`Mooswaldallee 1
`79090 Freiburg, Germany
`
`3.
`
`4.
`
`
`A.
`
`
`
`B.
`
`C.
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`(cid:190) Oral
`(cid:190) Capsule
`(cid:190) 200 mg and 250 mg
`
`METHOD(S) OF STERILIZATION:
`
`Not applicable
`
`PHARMACOLOGICAL CATEGORY: Cancer treatment
`
`Not applicable
`
`
`5.
`
`6.
`
`SUPPORTING/RELATED DOCUMENTS:
`
`REMARKS: The submission was provided in eCTD format. A product quality
`microbiology information request was sent to the applicant in June of 2011.
`
`
`filename: N202570R1.doc
`
`
`
`
`
`Reference ID: 2982022
`
`
`
`Page 2 of 6
`
`
`
`(b) (4)
`
`
`
`
`
`
`
`
`Microbiology Review # 1
`
`
`NDA 202-
`
`Executive Summary
`
`
`Recommendations
`
`A.
`
`
`Recommendation on Approvability -
`NDA 202-
` is recommended for approval from the standpoint of
`product quality microbiology.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable -
`Not applicable
`
`
`
`Summary of Microbiology Assessments
`
`I.
`
`II.
`
`
`
`B.
`
`A.
`
`
`
`
`B.
`
`
`A.
`
`
`B.
`
`
`C.
`
`
`C.
`
`
`III. Administrative
`
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology -
`The drug product will be
` dispensed into gelatin capsules.
`
`
`
`Brief Description of Microbiology Deficiencies -
`No product quality microbiology deficiencies were identified
`based upon the information provided.
`
`Assessment of Risk Due to Microbiology Deficiencies -
`Not applicable
`
`Reviewer's Signature _____________________________
`
`
`
`
`Stephen E. Langille
`
`Endorsement Block
`James McVey – Team Leader
`
`CC Block
`N/A
`
`
`
`
`
`Reference ID: 2982022
`
`
`
`Page 3 of 6
`
`
`
`3 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`(b) (4)
`
`(b) (4)
`
`(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/
`----------------------------------------------------
`
`STEPHEN E LANGILLE
`08/01/2011
`
`JAMES L MCVEY
`08/01/2011
`I concur.
`
`Reference ID: 2982022
`
`
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