Information request for BLA 125478/0, April 26, 2013 - RAGWITEK

From: Rivers, Katie
Sent: Friday, April 26, 2013 7:25 AM
To: 'scott.greenfeder@merck.com'
Cc: Valenti, Elizabeth; Sweeney, Colleen
Subject: Information Request

Dear Scott,

Your March 11, 2013, original submission contains information that appears to be identical to what was submitted to your January 25, 2013, BLA for Timothy Grass Pollen Allergen Extract. In an effort to facilitate and expedite our review, please identify the information located in Sections 1.12, 2.2, 2.3, and 3 that is identical in location and content to that contained in your Timothy Grass Pollen Allergen Extract submission.

Please let me know if you have any questions. If you would like to discuss via telephone, I can schedule a convenient time.

Thank you, 
Katie

Katie H. Rivers, M.S.
Regulatory Project Manager, RRB1
FDA/CBER/OVRR/DVRPA
1401 Rockville Pike, HFM-481
Rockville, MD 20852

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