Information request for BLA 125478/0, November 20, 2013 - RAGWITEK

(System Info - 256483 RIVERS KATIE 11/20/2013 12:04:02 RIVERSK)
From: Rivers, Katie
Sent: Wednesday, November 20, 2013 11:37 AM
To: 'Greenfeder, Scott'
Subject: Information request for BLA125478/0

Dear Scott, 
 We have the following information request for your BLA, STN125478/0:

We have reviewed your October 29, 2013, amendment to BLA 125478/0. We note that you analyzed –b(4)-------------- for measuring –b(4)--------------- using the –b(4)------------------------------------------------. Of these-----b(4)------------------------- are pilot scale and –b(4)---- are commercial scale batches that include process validation batches. In Section 3.2.P.5.4, Batch Analysis, Table 1 is a list of development, clinical, stability, and Process Performance Qualification (PPQ) batches for 12 Amb a 1 U tablets. This list also includes –b(4)----------; however, all of the batches in Table 1 have passed their expiration period except for –b(4)---- commercial batches manufactured in June 2012. It is unclear which batches were used in assessing b(4). Please identify exactly which –b(4)------ (including lot number) were used to measure b(4) as indicated in your October 29, 2013, amendment.

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
