CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:

205677Orig1s000
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:

6 June 2013

TO:

NDA 205677

FROM:

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

THROUGH:

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

cc:

Cathleen Michaloski, BSN, MPH
Sr. Regulatory Project Manager
OND/DNP

SUBJECT:

Product Quality Microbiology assessment of Microbial Limits for
Tasimelteon 20-mg capsules [Submission Date: 31 May 2013]

The Microbial Limits specification for Tasimelteon 20-mg capsules is acceptable from a
Product Quality Microbiology perspective. Therefore, this submission is recommended for
approval from the standpoint of product quality microbiology.
The drug product is a hard gelatin capsule 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).

Reference ID: 3320667

 MEMORANDUM
Table 1: Microbial Limits Specification
Test
Method
Total Aerobic Microbial Count USP <61>
Total Combined Yeast and USP <61>
Mold Count
USP <62>
Escherichia coli
USP <62>
Salmonella species
USP <62>
Pseudomonas aeruginosa
USP <62>
Staphylococcus aureus

NMT
NMT

Acceptance Criteria

Not detected in
Not detected in
Not detected in
Not detected in

(b) (4)

(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: 3320667

 --------------------------------------------------------------------------------------------------------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
06/06/2013
STEPHEN E LANGILLE
06/06/2013

Reference ID: 3320667