CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:

205641Orig1s000
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:

19 July 2013

TO:

NDA 205641

FROM:

Bryan S. Riley, Ph.D.
Team Leader (Acting)
OPS/New Drug Microbiology Staff

THROUGH:

Stephen E. Langille, Ph.D.
Senior Review Microbiologist
OPS/New Drug Microbiology Staff

cc:

Jessica K. Lee, PharmD
Regulatory Project Manager
OND/DPARP

SUBJECT:

Product Quality Microbiology assessment of Microbial Limits for
ASMANEX HFA [Submission Date: 27 June 2013]

The Microbial Limits specification for ASMANEX HFA (mometasone furoate) is acceptable
from a Product Quality Microbiology perspective. Therefore, this submission is recommended
for approval from the standpoint of product quality microbiology.
ASMANEX HFA is a

(b) (4)

suspension in a metered dose inhaler for oral inhalation.

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).

Reference ID: 3344435

 MEMORANDUM

Table 1 - Microbial Limits Speci?cation

 

Test Acceptance Criteria

Method

 

 

 

 

 

 

 

 

 

 

 

Total Aerobic Microbial Count NMT 3'3 USP <61>
Total Yeast and Mold Count NMT USP <61>
aureus Absence in gig USP <62>
Pseudomonas aemginosa Absence in USP <62>
Bile-tolerant gram-negative Absence in USP <62>
bacteria

 

The Microbial Limits test methods were veri?ed to be appropliate for use with the product
following procedures consistent with those in USP Chapter <61> and 

The drug product will also be tested for Microbial Limits at 0, 24 and 36 months 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: 3344435

 

--------------------------------------------------------------------------------------------------------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
07/22/2013
STEPHEN E LANGILLE
07/22/2013

Reference ID: 3344435