Draft Filing Letter, RAGWITEK

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service


Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Our STN: BL 125478/0

Merck Sharp & Dohme Corporation
Attention: Scott Greenfeder, Ph.D.
P.O. Box 2000, RY 33-204
126 East Lincoln Ave.
Rahway, NJ 07065

Dear Dr. Greenfeder:

This letter is in regard to your biologics license application (BLA), STN 125478.0, submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated March 11, 2013, for Short Ragweed Pollen Allergen Extract, tablets for sublingual use to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your BLA today. The review goal date is March 11, 2014. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.

At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.

If you have any questions, please contact the Regulatory Project Manager, Katie Rivers, M.S., at (301) 796-2640.

Sincerely yours,

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccine
Research and Review
Center for Biologics
Evaluation and Research
