Information Request for BLA125478/0, March 18, 2014 - Ragwitek

From: Rivers, Katie
Sent: Tuesday, March 18, 2014 8:41 AM
To: Greenfeder, Scott
Cc: Valenti, Elizabeth
Subject: Information Request for BLA125478/0
 Dear Scott,
 We have reviewed your responses to our CMC information request that you submitted on December 18, 2013 as an amendment to your BLA. We have the following questions and requests for additional information based on your responses:

CMC IR#6
 ------------------(b)(4)-------------------------- - In your response you indicate that in 2013 (b)(4) pollen lots were tested for ------(b)(4)------------------. Please provide the test results for these (b)(4) pollen lots.

CMC IR#20
 Expiration dating of human ---(b)(4)--- - You indicate that the ---(b)(4)--- is stored at ---(b)(4)----------- and is regarded as having shelf life for the duration of its use. Your response is not sufficient. Normally, ---(b)(4)--- and references are assigned an expiration date based on supportive testing data. Please indicate the shelf life assigned to your current --------(b)(4)------------------ based on your experience with the previous ---------(b)(4)------------------- and any supportive analytical tests. Please provide data supporting the shelf life of your ragweed ---(b)(4)----. In addition, please indicate if the human ---(b)(4)-- is tested on stability.

CMC IR#38 and 41
 Absence of specified organism testing for the post approval stability program – We request that you consider adding the absence of specified organism test to your future on-going stability protocols. You responded that the “results obtained from the stability program demonstrated that the formulation of the freeze dried tablet does not support microbial growth, showing that acceptable microbial quality has been demonstrated up to 36 months. As absence of specified microorganisms is confirmed at release, the presence of specified organisms is not expected to change over time. Therefore, the applicant proposes to perform only the Microbial Enumeration test -------------------------------------(b)(4)---------------------------------------------------------------------------- in accordance with ---(b)(4)-------- for the post-approval stability program.” We do not agree with your proposal at this time. Please include the absence of specified microorganisms test at Time Zero and at the end of your shelf-life study.

Please let me know if you have any questions.

Thank you,
 Katie

Katie H. Rivers, M.S.
 Regulatory Project Manager, CMC1
 FDA/CBER/OVRR/DVRPA
 1401 Rockville Pike, HFM-481
 Rockville, MD 20852

Phone 301-796-2640
 Fax 301-827-3532

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