`RESEARCH
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`APPLICATION NUMBER:
`206439Orig1s000
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`MICROBIOLOGY / VIROLOGY REVIEW(S)
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`M E M O R A N D U M
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`DATE:
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`TO:
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`FROM:
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`THROUGH:
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`cc:
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`SUBJECT:
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`13 May 2014
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`NDA 206439
`
`Bryan S. Riley, Ph.D.
`Team Leader (Acting)
`OPS/New Drug Microbiology Staff
`
`John W. Metcalfe, Ph.D.
`Senior Review Microbiologist
`OPS/New Drug Microbiology Staff
`
`Teresa A. Wheelous, R.Ph.
`Senior Regulatory Project Manager
`OND/DNP
`
`Product Quality Microbiology assessment of Microbial Limits for
`NAMZARIC (memantine HCl extended release/donepezil HCl
`capsules) [Submission Date: 26 February 2014]
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`The Microbial Limits specification for NAMZARIC is acceptable from a Product Quality
`Microbiology perspective. Therefore, this submission is recommended for approval from the
`standpoint of product quality microbiology.
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`NAMZARIC is a Capsule for oral administration.
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`The drug product is tested for Microbial Limits at release using a method consistent with USP
`Chapter <61> (Microbiological Examination of Non-sterile Products: Microbial Enumeration
`Tests) and <62> (Microbiological Examination of Non-sterile Products: Tests for Specified
`Microorganisms). The Microbial Limits acceptance criteria are consistent with USP Chapter
`<1111> (Microbiological Examination of Non-sterile Products: Acceptance Criteria for
`Pharmaceutical Preparations and Substances for Pharmaceutical Use).
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`Reference ID: 3508198
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`
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`MEMORANDUM
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`Table 1 — Microbial Limits Specifications
`Test
`Total Aerobic Microbial Count (USP <61>)
`Total Yeast and Mold Count (USP <61>)
`E. coli (USP <62>)
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`Acceptance Criteria
`NMT
`(m4)
`NMT
`on»
`Absent in
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`The Microbial Limits test methods were verified to be appropriate for use with the drug product
`following procedures consistent with those in USP Chapter <6l> and <62>.
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`The drug product will also be tested for Microbial Limits annually as part of the post-approval
`stability protocol.
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`ADEQUATE
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`Reviewer Comments — The microbiological quality of the drug product is controlled via a
`suitable testing protocol.
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`END
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`Reference ID: 3508198
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`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
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`/s/
`----------------------------------------------------
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`BRYAN S RILEY
`05/16/2014
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`JOHN W METCALFE
`05/16/2014
`I concur.
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`Reference ID: 3508198
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