`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`21-462
`
`Microbiology Review(s)
`
`
`
`Product Quality Microbiology Review
`Review for HFD-150
`
`29 October 2003
`
`NDA: NDA 21-462
`
`Drug Product Name
`Proprietary: Alimta
`Non-proprietary: pemetrexed disodium
`Drug Product Classification: anti-cancer
`
`Review Number: 1
`
`'
`
`Subject of this Review
`Submission Date: 29 September 2003
`Receipt Date: 30 September 2003
`Consult Date: 10 October 2003
`
`Date Assigned for Review: 20 October 2003
`
`. Submission History (for amendments only)
`Date(s) of Previous Submission(s):
`Date(s) of Previous Micro Review(s):
`
`Applicant/Sponsor
`Name: Eli Lilly and Company
`Address: Lilly Corporate Center, Indianapolis, IN 46285
`Representative: Jeffery Ferguson
`Telephone: (317)433—5615
`
`Name of Reviewer: Paul Stinavage
`
`Conclusion: The application is recommended for approval on the basis of
`sterility assurance.
`
`
`
`NDA 21-462
`
`Microbiology Review #1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`TYPE OF SUPPLEMENT: Not Applicable
`
`SUPPLEMENT PROVIDES FOR: Not Applicable
`
`MANUFACTURING SITE: Fegersheim, France
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: 500 mg sterile lyophilized powder per vial
`
`METHOD(S) OF STERILIZATION:
`
`’7‘"
`
`PHARMACOLOGICAL CATEGORY: Anticancer
`
`B.
`
`SUPPORTING/RELATED DOCUMENTS:
`
`V C.
`
`.-— submission of the — NDA adds the Lilly facility
`REMARKS: This ,
`at Fegersheim, France as an additional manufacturing site for the
`vial configuration of the product. The submission references Type
`V DMF — ‘ for the Fegersheim facility. The DMF review has
`been previously completed by this reviewer and found adequate to
`support approval of this application. See Microbiologist’s Review
`of Type V DMF ~— 7 dated 19 March 2003.
`
`Vfilename: N21462.doc
`
`Page 2 of 6
`
`
`
`NDA 21-462
`
`Microbiology Review #1
`
`Executive Summary
`
`1.
`
`Recommendations
`
`A.
`
`' Recommendation on Approvability — The submission is
`recommended for approval on the basis of sterility assurance.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable -
`
`II.
`
`Summary of Microbiology Assesméhts .
`
`_ A.
`
`"Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology “4
`’—
`
`B.
`
`C.
`
`Brief Description of Microbiology Deficiencies -
`
`Assessment of Risk Due to Microbiology Deficiencies -
`
`11].
`
`Administrative
`A.
`Reviewer's Signature
`
`\
`5%
`
`B.
`
`Endorsement Block
`
`Paul Stinavage
`Peter H. Cooney
`
`C.
`
`CC Block
`
`cc: P. Garvey
`Original NDA 21-462
`HFD-l SO/Division File/NDA 21-462
`
`Page 3 of 6
`
`
`
`Redégted _ ___‘a_____
`
`pages of trade
`
`sécfét and/or
`
`_/i¢onfidential
`
`commerCial. _
`
`§‘inf0rmation
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Paul Stinavage
`11/7/03 12:55:23 PM
`MICROBIOLOGIST
`
`Product manufacture at Fegersheim facility.
`
`I Peter Cooney
`11/7/03 01:48:23 PM
`-MICROBIOLOGIST
`
`
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