CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:

205718Orig1s000
MICROBIOLOGY / VIROLOGY REVIEW(S)

 MEMORANDUM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH

DATE:

October 2, 2013

TO:

NDA 205718

FROM:

John W. Metcalfe, Ph.D.
Senior Microbiology Reviewer
CDER/OPS/NDMS

THROUGH:

Stephen E. Langille, Ph.D.
Senior Microbiology Reviewer
CDER/OPS/NDMS

cc:

Mary Chung, PharmD.
Regulatory Health Project Manager
CDER/OND/ODEIII/DGIEP

SUBJECT:

Product Quality Microbiology assessment of Microbial Limits for
NDA 205718 [Submission Date: 26 September 2013]

The Microbial Limits specification for Netupitant and Palonosetron (Fixed Dose
Combination Capsule) is acceptable from a Product Quality Microbiology perspective.
Therefore, this submission is recommended for approval from the standpoint of product
quality microbiology.
Netupitant and Palonosetron (Fixed Dose Combination Capsule) is a Tablet/Capsule combination
for oral administration.
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). The Microbial Limits
acceptance criteria are provided in table 1.

Reference ID: 3383098

 MEMORANDUM
Table 1. Microbial Limits Tests and Acceptance Criteria
Test
Method
Total Aerobic Microbial Count
USP<61>
Total Combined Yeasts/Molds Count
USP<61>
Escherichia coli
USP<62>

Acceptance Criteria
(b) (4)

The Microbial Limits test methods were verified to be appropriate for use with the drug product
following procedures consistent with those in USP Chapter <61> and <62>.
The drug product will also be tested for Microbial Limits annually as part of the post-approval
stability protocol.
ADEQUATE
Reviewer Comments – The microbiological quality of the drug product is controlled via a
suitable testing protocol.
END

Reference ID: 3383098

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------JOHN W METCALFE
10/02/2013
STEPHEN E LANGILLE
10/02/2013

Reference ID: 3383098