`RESEARCH
`
`
`APPLICATION NUMBER:
`207620Orig1s000
`
`MICROBIOLOGY / VIROLOGY REVIEW(S)
`
`
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`
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`
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`0"
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`p/C
`(519%
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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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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`PUBLIC HEALTH SERVICE
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`FOOD AND DRUG ADMINISTRATION
`
`03 February 2015
`
`NDA 207620
`
`Robert J. Mello, PhD.
`Senior Review Microbiologist
`CDER/OPQ/OPF/DMA
`
`Neal J. Sweeney, Ph.D.
`Senior Review Microbiologist
`CDER/OPQ/OPF/DMA
`
`Olga Simakova
`Regulatory Health Project Manager
`CDER/OPQ/OPRO
`
`Filing Review and Product Quality Microbiology assessment of
`Microbial Limits for LCZ696 (sacubitril/valsartan) 50mg, 100mg and
`200mg film coated tablets [Submission Date: 09 September 2014].
`
`Description: The drug product, LCZ696 (sacubitril/valsartan) 50 mg, 100 mg, 200 mg fihn—coated
`tablet is an immediate release dosage form for oral administration. The 50mg dosage form is a violet
`white, ovaloid, biconvex fihn—coated tablet with beveled edges, unscored, debossed with “NVR” on
`one side and “LZ” on the other side. The 100mg dosage form is a pale yellow, ovaloid, biconvex film-
`coated tablet with beveled edges, unscored, debossed with “NVR” on one side and “L1” on the other
`side. The 200mg dosage form is a light pink, ovaloid, biconvex fihn—coated tablet with beveled edges,
`lmscored, debossed with “NVR” on one side and “L11” on the other side. AH three dosage forms will
`be produced at the Novartis Stein Switzerland Facility.
`
`(m4)
`It is noted here that the NDA contains a comparability protocol for the post approval
`. There are no microbiology review
`
`issues to address in the comparability protocol.
`
`The description ofthe manufacturing process indicates that the
`
`0’) (4)
`a»m)
`
`Composition: The composition of the core is shown in Table 2-1, below (copied from submission
`section 3.2.P. 1, pages 3-4/4; highlighted portion added by reviewer).
`
`2 Pages Have Been Withheld In Full As b4 (CCIITS) Immediawa Following This Page
`
`
`
`M E M O R A N D U M
`
`Combined Filing Review and Primary Review for NDA 207620
`
`Endorsement page:
`
`Robert J. Mello, Ph.D.
`Senior Microbiology Reviewer
`OPQ/OPF/DMA
`
`Robert J.
`Mello -A
`
`Digitally signed by Robert J. Mello
`-A
`DN: c=US, o=U.S. Government,
`ou=HHS, ou=FDA, ou=People,
`0.9.2342.19200300.100.1.1=1300
`369984, cn=Robert J. Mello -A
`Date: 2015.02.05 14:53:08 -05'00'
`
`Neal J. Sweeney, Ph.D.
`Senior Microbiology Reviewer
`OPQ/OPF/DMA
`
`Neal J.
`Sweeney -A
`
`Digitally signed by Neal J.
`Sweeney -A
`DN: c=US, o=U.S. Government,
`ou=HHS, ou=FDA, ou=People,
`0.9.2342.19200300.100.1.1=13001
`09587, cn=Neal J. Sweeney -A
`Date: 2015.02.05 14:58:04 -05'00'
`
`
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