`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`RESEARCH
`
`APPLICATION NUMBER:
`APPLICA TION NUMBER:
`22-334
`22-334
`
`MICROBIOLOGY REVIEW(S)
`MICROBIOLOGY REVIEW! S!
`
`
`
`Product Quality Microbiology Review
`
`20 MARCH 2009
`
`NDA:
`
`NDA 22-334/N-000
`
`Drug Product Name
`Proprietary:
`Non-proprietary:
`
`AfinitorCI
`everolimus
`
`Review Number:
`
`1
`
`Dates of Submission(s) Covered by this Review
`Letter Stamp Review Request
`27 JUNE 2008 30 JUNE 2008 24 JULY 2008
`09 SEP 2008 (Be) 09 SEP 2008 n/a
`20 JAN 2009 (BC) 21 JAN 2009 n/a
`
`Assigned to Reviewer
`29 JULY 2008
`n/a
`n/a
`
`Submission History (for amendments only): N/A
`
`Applicant/Sponsor
`Name:
`Address:
`
`Representative:
`
`Telephone:
`
`N ovartis Pharmaceuticals Corporation
`One Health Plaza
`East Hanover, New Jersey 07936-1080
`Sibylle R. Jennings, Ph.D.
`Associate Dir. Drug Regulatory Affairs
`(862) 778-1196
`
`N arne of Reviewer:
`
`Robert J. Mello, Ph.D.
`
`Conclusion:
`
`The application is recommended for
`approval from microbiology product
`quality standpoint.
`
`
`
`NDA 22-334/N-000 .
`
`Microbiology Review # 1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`TYPE OF SUBMISSION: New NDA
`
`2. SUBMISSION PROVIDES FOR: Marketing Approval
`
`3.
`
`MAFACTURING SITE:
`
`Novartis Pharma Stein AG
`Schaffhauserstrasse
`CH-4332 Stein
`Switzerland
`
`4. DOSAGE FORM, ROUTE OF ADMINISTRATION AN
`STRENGTHIOTENCY: Tablet; Oral; 5mg and 10mg
`
`5. METHOD(S) OF STERILIZATION: N/A
`
`6. PHAMACOLOGICAL CATEGORY: Anti-neoplastic drug
`
`B. SUPPORTINGIRLATED DOCUMENTS: None
`
`C. REMAKS:
`· The ONDQA PAL Initial Quality Assessment was submitted to DFS on 04 AUG
`2008. No microbiology issues were identified in that review.
`· The submission, in electronic eCTD format, was available via the Global Submit
`document system.
`· This 505 (b)(1) application was granted Priority Review designation in DSS.
`There were numerous amendments to the submission (42 items within the Global
`submit system).
`· On 30 OCT 2008 the original 30 DEC 2008 goal date was extended to the new
`date of March 2009 as a result ofthe receipt ofa major amendment.
`· The AfinitonI tablet (everolimus) was formerly known as "RADOO 1 " during the
`development program. As a result, much ofthe submitted documentation refers
`toRAOOl.
`
`Filename: N022334NOOORl.doc
`
`Page 2 of8
`
`
`
`NDA 22-334/N-000
`
`Executive Summary
`
`I. Recommendations
`
`Microbiology Review # 1
`
`A. Recommendation on Approvabilty - Recommend Approval
`
`B. Recommendations on Phase 4 Commitments and/or Agreements,
`if Approvable -
`
`II. Summary of Microbiology Assessments
`
`A. Brief
`
`Description ofthe Manufacturing Processes that relate to
`Product Quality Microbiology - The oral tablets are prepared in ._
`
`\\t.)
`
`B. Brief Description of Microbiology Deficiencies - None
`
`C. Assessment of Risk Due to Microbiology Deficiencies - N/ A
`
`III. Administrative
`
`A. Reviewer's Signature
`
`B. Endorsement Block
`
`c. CC Block
`NDA22-334
`
`Robert Mello, Ph.D.
`
`Bryan S. Riley, Ph.D.
`
`Page 3 of8
`
`
`
`q Page(s) Withheld
`
`\/ Trade Secret / Confidential (b4)
`
`Draft Labeling (b4)
`
`Draft Labeling (bS)
`
`Deliberative Process (bS)
`
`Withheld Track Number: Microbiology- ~
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`/s/
`Robert Mello
`3/20/2009 11: 23: 46 AM
`MICROBIOLOGIST
`
`Recommend Approval
`
`Bryan Riley
`3 /2 0/2 0 09 12: 2 8 : 44 PM
`MICROBIOLOGIST
`I concur.
`
`
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