`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`
`
`APPLICATION NUMBER:
`22-264
`22-264
`
`
`MICROBIOLOGY REVIEW(S)
`MICROBIOLOGY REVIEWgSg
`
`
`
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`
`04 May 2009
`
`22-264/N-000 AZ
`
`Invega® Sustenna™
`paliperidone palmitate
`
`1
`
`Assigned to
`Reviewer
`12 MAR 2009
`
`Ortho-McNeil-Janssen
`Pharmaceuticals, Inc.
`
`Johnson & Johnson
`Pharmaceutical R&D, L.L.C.
`1125 Trenton-Harbourton Rd.
`PO Box 200
`Titusville, NJ 08560
`
`Dawn Kracht
`609-730-3082
`
`John W. Metcalfe, Ph.D.
`
`Recommend approval.
`
`
`Review Number:
`
`Dates of Submission(s) Covered by this Review
`Letter
`Stamp
`Review Request
`03 FEB 2009
`03 FEB 2009
`03 MAR 2009
`
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`Non-proprietary:
`
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`
`
`
`
`
`
`Representative:
`Telephone:
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
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`NDA 22-264/N-000 AZ
`
`
`Microbiology Review #1
`
`
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION: Amendment to NDA.
`
`2.
`
`3.
`
`
`4.
`
`
`5.
`
`6.
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`
`
`SUBMISSION PROVIDES FOR: A Complete Response Document which
`addresses the items provided in the Agency’s Complete Response Letter (25
`August 2008). The 03 February 2009 Complete Response Document
`includes the addition of the applicant’s Cork, Ireland facility for manufacture
`of the drug substance.
`
`MANUFACTURING SITE:
`Previously Identified DS & DP Manuf Site:
`Janssen Pharmaceutica N.V.
`Turnhoutseweg 30
`B-2340 Beerse
`Belgium
`
`Proposed Additional DS Manuf Site:
`Janssen Pharmaceutical
`Little Island
`County Cork, Republic of Ireland
`Cork, Ireland
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`(cid:190) Suspension for injection in pre-filled plastic syringe.
`(cid:190) Intramuscular injection.
`(cid:190) 25, 50, 75, 100 & 150 mg eq.
`
`METHOD(S) OF STERILIZATION:
`
`.
`
`PHARMACOLOGICAL CATEGORY: The subject drug product is
`indicated for the treatment of schizophrenia and for prevention of recurrence
`of symptoms of schizophrenia.
`
`SUPPORTING/RELATED DOCUMENTS:
`(cid:190) Microbiology Review of Type II DMF 20902; Paliperidone Palmitate
`(R092670) Drug Substance. Johnson & Johnson Pharmaceutical R & D,
`L.L.C (dated 18 June 2008).
`(cid:190) Microbiology Review of Type II DMF 20902; Paliperidone Palmitate
`(R092670) Drug Substance. Johnson & Johnson Pharmaceutical R & D,
`L.L.C (dated 20 April 2009).
`
`
`
`
`A.
`
`B.
`
`
`C.
`
`
`
`REMARKS:
`The submission is submitted electronically in the eCTD format.
`
`
`
`
`
`
`
`File Name: N022264AZR1.doc
`
`
`
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`Page 2 of 6
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`
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`(b) (4)
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`
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`Microbiology Review #1
`
`
`NDA 22-264/N-000 AZ
`
`Executive Summary
`
`
`Recommendations
`
`A.
`
`Recommendation on Approvability – NDA 22-264/N-000 AZ is
`recommended for approval on the basis of microbiological product
`quality.
`
`Recommendations on Phase 4 Commitments and/or Agreements,
`if Approvable – Not applicable.
`
`
`Summary of Microbiology Assessments
`
`I.
`
`II.
`
`
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`B.
`
`A.
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`B.
`
`
`C.
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`A.
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`
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`B.
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`
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`C.
`
`
`III. Administrative
`
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology – The subject drug product is
` manufactured.
`
`Brief Description of Microbiology Deficiencies – There are no
`microbiology deficiencies identified.
`
`Assessment of Risk Due to Microbiology Deficiencies – Not
`applicable.
`
`Reviewer's Signature _____________________________
`
`
`
`
`John W. Metcalfe, Ph.D.
`
`Endorsement Block_______________________________
`
`
`
`
`Stephen Langille, Ph.D.
`
`CC Block
`N/A
`
`
`
`
`
`
`
`Page 3 of 6
`
`
`
`3 pages withheld immediately
`following this page as (b)(4) CCI/TS.
`
`(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/
`---------------------
`John Metcalfe
`5/4/2009 11:34:50 AM
`MICROBIOLOGIST
`
`Stephen Langille
`5/4/2009 01:42:18 PM
`MICROBIOLOGIST
`
`
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