Proprietary Name Review 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 Corp.
Attention: Scott Greenfeder, Ph.D.
126 E. Lincoln Avenue
P.O. Box 2000
Rahway, NJ 07065

Dear Dr. Greenfeder:

We have reviewed your March 22, 2013, submission to your biologics license application (BLA) for Short Ragweed Pollen Allergen Extract requesting a proprietary name review.

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB), we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, RAGWITEK, is acceptable at this time.

We will perform another proprietary name review of RAGWITEK closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.

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

Sincerely yours,

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