`RESEARCH
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`APPLICATION NUMBER:
`206321Orig1s000
`
`MICROBIOLOGY / VIROLOGY REVIEW(S)
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`silVICEJv
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`DEPARTNIENT OF HEALTH AND HUMAN SERVICES
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`PUBLIC HEALTH SERVICE
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`FOOD AND DRUG ADNIINISTRATION
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`DATE:
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`14 January 2014
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`TO:
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`NDA 206321
`
`FROM:
`
`Bryan S. Riley, PhD.
`Team Leader (acting)
`OPS/New Drug Microbiology Staff
`
`THROUGH: Stephen E. Langille, PhD.
`Master Review Microbiologist
`OPS/New Drug Microbiology Staff
`
`CC:
`
`Patricia Madara
`Regulatory Project Manager
`OND/DMEP
`
`Priyanka Kumar
`Regulatory Pr0ject Manager
`OPS/ONDQA
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`SUBJECT:
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`review of NDA 206321, Liraglutide injection
`Product Quality Microbiolo
`(submission date 20 Decem er 2013).
`
`This submission is recommended for approval from a product quality microbiology
`standpoint.
`
`This NDA refers to approved NDA 22-341 for Victoza (liraglutide injection 1.8 mg). (6)“)
`
`. The only significant difference from a product quality microbiology
`standpoint is the proposed maximum dose for the subject NDA is greater (3.0 ngday) than for
`the approved NDA 22-341 (1.8 mg/day). However, the proposed endotoxin specification ( M0
`IU/mL) is acceptable for the maximum dose of 3.0 mg/day.
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`ADEQUATE
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`Reviewer Comments - The proposed drug product is identical to an approved drug
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`product from a product quality microbiology perspective. Therefore, no additional product
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`1
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`Reference ID: 3437229
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`M E M O R A N D U M
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`quality microbiology assessment is necessary.
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`END
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`2
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`Reference ID: 3437229
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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.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BRYAN S RILEY
`01/15/2014
`
`STEPHEN E LANGILLE
`01/16/2014
`
`Reference ID: 3437229
`
`