`
`CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`21-660
`
`MICROBIOLOGY REVIEW! S!
`
`
`
`
`
`Product Quality Microbiology Review
`Review for HFD 150
`
`7-May—2004
`
`NDA:
`
`Drug Product Name:
`Non-proprietary
`
`Drug Product Classification:
`
`Review Number:
`
`Subject of this Review
`Submission Date:
`
`Receipt Date:
`Consult Date:
`
`Date Assigned for Review:
`
`21 —660/RR1—004
`
`_—-o
`
`Nanoparticle Paclitaxel for
`Injectable Suspension
`
`February 27, 2004
`March 1, 2004
`
`March 3, 2004
`
`March 24, 2004
`
`Submission History (for amendments only)
`Date(s) of Previous Submission(s):
`
`June 30, 2003
`
`Date(s) of Previous Micro Review(s):
`
`February 19, 2004
`
`Applicant/Sponsor
`Name:
`
`Address:
`
`American Bioscience, Inc
`
`2730 Wilshire Blvd, Suite 10
`
`Santa Monica, CA 90403
`
`Representative:
`Telephone:
`
`Mitchall Clark
`
`(310) 883-3141
`
`Name of Reviewer:
`
`Stephen E. Langille, PhD.
`
`Conclusion:
`
`Recommended for approval
`
`
`
`
`
`NDA 21-660
`Microbiology Review # l
`
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`TYPE OF SUPPLEMENT:
`
`Original Application
`
`SUPPLEMENT PROVIDES FOR:
`
`Not applicable
`
`MANUFACTURING SITE:
`
`American Pharmaceutical
`Partners, Inc.
`
`2020 Ruby St.
`Melrose Park, IL 60160
`
`DOSAGE FORM; ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`o
`
`-
`
`0
`
`Sterile lyophilized
`powder
`Intravenous infusion
`
`100 lug/vial
`
`METHOD(S) OF STERILIZATION:
`
`fl “-
`
`PHARMACOLOGICAL CATEGORY: Cancer therapy
`
`B.
`
`SUPPORTING/RELATED DOCUNIENTS:
`
`DMF — and 21-660 form
`
`483 for pro—approval
`inspection issues
`
`C.
`
`REMARKS: NDA 21-660 was filed electronically.
`
`filcname: c:\reviews\21-660r2.doc
`
`—___.__.—.__.——___—.—.———-————n-—————
`
`Page 2 of 10
`
`
`
`
`
`NDA 21—660
`
`Microbiology Review # 1
`
`Executive Summary
`
`I.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability -
`NDA 21-660 is recommended for approval from the standpoint of
`product quality microbiology.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvahle -
`Not applicable
`
`[1.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology -
`An
`._
`. iyophilized powder will be manufactured
`at American Pharmaceutical Partners, Inc., Melrosc Park, IL.
`
`Brief Description of Microbiology Deficiencies -
`No microbiology deficiencies were found based upon the
`information provided.
`
`Assessment of Risk Due to Microbiology Deficiencies -
`Not applicable
`
`III.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer's Signature
`
`Endorsement Block
`
`Stephen E. Langille, PhD.
`Peter Cooney, PhD.
`
`CC Block
`111 DPS
`
`Page 3 of 10
`
`
`
`7 Page(s) Withheld
`
`___[§ 552(b)(4) Trade Secret / Confidential
`
`§ 552(b)(5) Deliberative Process
`
`§ 552(b)(5) Draft Labeling
`
`
`
` ---—‘I...--III."-----------------‘u-fl------n-—n.-nunn-n---------------------—----nnu-u-nu-Iu-Iu-IIIII-IIU-I—un-----
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`-__-____-_-..-uu--——--____-----nu-—-_-___--_-n-au---u-u-nn——-----——-----------nu---—--—------—--—-u—-—----------—---
`
`/S/
`
`Stephen Langille
`5/24/04 02:36:08 PM
`MICROBIOLOGIST
`
`Peter Cooney
`5/24/04 02:49:03 PM
`MICROBIOLOGIST
`
`
`
`
`
`Product Quality Microbiology Review
`Review for HFD 150
`
`lZ-February-2004
`
`NDA:
`
`21-660
`
`Drug Product Name:
`Non-proprietary
`
`— m
`Nanoparticle Paclitaxel for
`Injectable Suspension
`
`Drug Product Classification:
`
`Review Number:
`
`1
`
`Subject of this Review
`Submission Date:
`Receipt Date:
`Consult Date:
`Date Assigned for Review:
`
`June 30, 2003
`June 30, 2003
`September 16, 2003
`October 24, 2003
`
`Submission History (for amendments only)
`Date(s) of Previous Submission(s):
`Date(s) of Previous Micro Review(s):
`
`Applicant/Sponsor
`Name:
`
`Address:
`
`American Bioscienee, Inc
`
`2730 Wilshire Blvd, Suite 10
`
`Santa Monica, CA 90403
`
`Representative:
`Telephone:
`
`Mitchall Clark
`(310) 883-3141
`
`Name of Reviewer:
`
`Stephen E. Langille, PhD.
`
`Conclusion:
`
`Approx/able pending revision
`
`
`
`NDA 21-660
`
`Microbiology Review # 1
`
`Product Quality Microbiology Data Sheet
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`TYPE OF SUPPLEMENT:
`
`Original Application
`
`SUPPLEMENT PROVIDES FOR:
`
`Not applicable
`
`MANUFACTURING SITE:
`
`American Pharmaceutical
`
`Partners, Inc.
`
`2020 Ruby St.
`Melrose Park, IL 60160
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTHIPOTENCY:
`
`0
`
`0
`
`-
`
`Sterile lyophilized
`powder
`Intravenous infusion
`
`100 mg/vial
`
`METHOD(S) OF STERILIZATION :
`
`-—""
`
`PHARMACOLOGICAL CATEGORY: Cancer therapy
`
`SUPPORTING/RELATED DOCUMENTS:
`
`DMF
`
`"—
`
`REMARKS: NDA 21—660 was filed electronically.
`
`A.
`
`B.
`
`C.
`
`filename: c:\reviews\21-660rl .doc
`
`Page 2 of 19
`
`
`
`NDA 21-660
`Microbiology Review # 1
`
`
`Executive Summary
`
`I.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability -
`NDA 21-660 is approvable pending the revision of microbiological
`deficiencies.
`'
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable -
`Not applicable
`
`11.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology -
`An
`_
`j'j’
`lyophilized powder will be manufactured
`at American Pharmaceutical Partners, Inc, Melrose Park, IL.
`
`Brief Description of Microbiology Deficiencies -
`The Applicant failed to provide:
`-
`adequate documentation for
`sterilization validation.
`
`_.
`
`- A detailed description of the storage conditions for the
`
`Assessment of Risk Due to Microbiology Deficiencies -
`Failure to address the microbiology deficiencies may result in
`contamination of the drug product cm":-
`d
`
`111.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer‘s Signature
`
`Endorsement Block
`
`Stephen E Langille, PhD.
`Peter Cooney, PhD.
`
`CC Block
`In DFS
`
`
`
`Page 3 of l9
`
`
`
`
`
`____/£_ Page(s) Withheld"
`
`______/§ 552(b)(4) Trade Secret / Confidential
`
`§ 552(b)(5) Deliberative Process
`
`_
`
`.
`
`§552(b)(5) Draft Labeling
`
`
`
`
`
`.---——-—------__---—--u-nunm------n--——-u--__--___- __.. _----_—--__.. __------ --u-.q.---_-.-----u----¢n---n----unnuuumn
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature
`
`/9/
`
`Stephen Langille
`2/20/04 09:28:56 AM
`MICROBIOLOGIST
`
`Peter Cooney
`2/20/04 01:21:25 PM
`MICROBIOLOGIST
`
`
`
`
`
`
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