CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`'
`
`'
`
`APPLICA TION NUMBER:
`
`2 1 -8 9 7
`
`MICROBIOLOGY REVIEW
`
`
`
`RESEARCH
`
`'
`
`'
`
`APPLICA TION NUMBER:
`
`2 1 -8 9 7
`
`MICROBIOLOGY REVIEW
`
`
`
`Product Quality Microbiology Review
`Review for HFD-170
`
`24-October-2005
`
`NDA:
`
`'
`
`NDA 21-897-BI
`
`Drug Product Name
`VIVITREX®
`Proprietary:
`naltrexone injection
`Non-proprietary:
`Drug Product Priority Classification: Priority
`
`Review Number:
`
`>
`
`2
`
`Dates of Submission s Covered b this Review
`
`Consult Sent Assi_ned to Reviewer 10/3/05
`
`10/19/05
`
`10/3/05
`
`10/19/05
`
`Submission Histo
`
`
`
`Submission Date(s)
`3/31/05
`
`
`
`
`
`Applicant/Sponsor
`Name:
`Address:
`
`for amendments onl
`
`
`Microbiolo 3 Review #
`
`Review Date(s)
`9/23/05
`
`
`
`
`Alkermes, Inc.
`88 Sidney St.
`Cambridge, MA 02319
`
`Representative:
`Telephone:
`
`-
`
`Priya Jambhekar
`(617) 583-6547
`
`Name of Reviewer:
`
`Stephen E. Langille, Ph.D.
`
`Conclusion:
`
`Recommended for approval
`
`
`
`NDA 21-897-BI
`
`Microbiology Review # 2
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`TYPE OF SUBMISSION:
`
`SUBMISSION PROVIDES FOR:
`
`Amendment to the Original
`submission
`
`‘— of
`Vivitrex®
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`MANUFACTURING SITE:
`
`Alkermes Controlled
`
`Therapeutics, II (Alkermes,
`Inc.)
`265 Olinger Circle
`Wilmington, OH 45177
`Tel: (937) 382-5642
`CFN #: 1528810
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`o
`0
`
`-
`
`Injectable suspension
`Intra-muscular
`
`380 mg
`
`METHOD(S) OF STERILIZATION:
`
`m...‘
`
`PHARMACOLOGICAL CATEGORY: Treatment of alcohol
`
`dependence
`
`B.
`
`C.
`
`SUPPORTING/RELATED DOCUMENTS:
`
`DMF
`
`“kw
`
`REMARKS:
`
`filename: N021897Rl.doc
`
`Page 2 of 9
`
`
`
`NDA 21-897-BI
`Microbiology Review # 2
`
`
`Executive Summary
`
`I.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability -
`NDA 21-897 is recommended for approval from the standpoint of
`product quality microbiology.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable —
`Not applicable
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology -
`
`/
`
`/
`
`/
`
`/ /
`
`B.
`
`C.
`
`Brief Description of Microbiology Deficiencies -
`No deficiencies were identified based upon the information
`provided.
`
`Assessment of Risk Due to Microbiology Deficiencies -
`Failure to address the microbiology deficiencies could lead to
`microbial and/or endotoxin contamination of the drug product.
`
`III.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer's Signature
`
`Endorsement Block
`
`Microbiology Supervisor/Team Leader Name
`
`.CC Block
`N/A
`
`Page 3 of 9
`
`
`
`é Page(s) Withheld
`
`_/
`
`Trade Secret / Confidential I
`
`I
`
`Draft Labeling _
`
`-——_“»
`
`Deliberative Process.
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Stephen Langille
`10/24/2005 12:44:09 PM
`MICROBIOLOGIST
`
`Bryan Riley
`10/24/2005 12:48:49 PM
`MICROBIOLOGIST
`
`
`
`Product Quality Microbiology Review
`Review for HFD-170
`
`19—September-2005
`
`NDA:
`
`NDA 21-897
`
`Drug Product Name
`VIVITREX®
`Proprietary:
`naltrexone injection
`Non-proprietary:
`Drug Product Priority Classification: Priority
`
`Review Number:
`
`1
`
`Dates of Submission s Covered b this Review
`
`3/31/05
`
`3/31/05
`
`
`5/13/05
`
`8/22/05
`
`
`
`
`Submission Date(s)
`Microbiolo ; Review #
`Review Date(s)
`
`Not ao olicable
`Not ao olicable
`Not ao olicable
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Applicant/Sponsor
`Name:
`
`Address:
`
`Alkermes, Inc.
`
`88 Sidney St.
`Cambridge, MA 02319.
`
`Representative:
`Telephone:
`
`Priya Jambhekar
`(617) 583-6547
`
`Name of Reviewer:
`
`Stephen E. Langille, Ph.D.
`
`Conclusion:
`
`Approvable pending revision
`
`
`
`Microbiology Review # 1
`NDA 21-897
`
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`B.
`
`C.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`TYPE OF SUBMISSION:
`
`Original submission
`
`SUBMISSION PROVIDES‘FOR:
`
`_’\_~
`Vivitrex®
`
`- of
`
`MANUFACTURING SITE:
`
`Alkermes Controlled
`Therapeutics, II (Alkermes,
`Inc.)
`265 Olinger Circle
`Wilmington, OH 45177
`Tel: (937) 382—5642
`CFN #: 1528810
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`METHOD(S) OF STERILIZATION:
`
`o
`-
`
`0
`
`Injectable suspension
`Intra-muscular
`
`3 80 mg
`
`P—If“
`
`PHARMACOLOGICAL CATEGORY: Treatment of alcohol
`dependence
`
`SUPPORTING/RELATED DOCUMENTS:
`
`DMF /
`
`REMARKS:
`
`filename: N021897R1.doc
`
`___________.__—___——-—-———————
`
`Page 2 of 20
`
`
`
`Microbiology Review # l
`NDA 21-897
`_____—___._._————-———————————
`
`Executive Summary
`
`1.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability -
`NDA 21-897 is approvable pending the resolution of microbiology
`deficiencies.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable -
`Not applicable
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology -
`
`-/ /
`
`/
`
`/
`
`/
`
`/
`
`B.
`
`Brief Description of Microbiology Deficiencies -
`The applicant failed to provide adequate information regarding:
`
`/
`
`/./
`
`C.
`
`Assessment of Risk Due to Microbiology Deficiencies -
`Failure to address the microbiology deficiencies could lead to
`microbial and/or endotoxin contamination of the drug product.
`
`III.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer's Signature
`
`Endorsement Block
`Microbiology Supervisor/Team Leader Name
`
`CC Block
`N/A
`
`____——____—_—__—-———————'_———
`
`Page 3 of 20
`
`
`
`__
`
`'.
`
`[é V Page(s) Withheld '
`
`Trade Secret / Confidential I
`
`'
`
`Draft Labeling _
`
`Deliberative Process.
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Stephen Langille
`9/23/2005 08:54:27 AM
`MICROBIOLOGIST
`
`Bryan Riley
`9/23/2005 09:03:13 AM
`MICROBIOLOGIST
`
`
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