Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

PNA Letter - GLASSIA

DEPARTMENT OF HEALTH & HUMAN SERVICES   
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Our STN: 125325/0           

Kamada Ltd.
Attention: ----------(b)(4)----------
-------------------------------------------------
--------------------------
------------------------------------ 
Dear ----(b)(4)-----:

We reviewed your December 30, 2009 submission to your biologics license application (BLA) for Alpha-1-Proteinase Inhibitor (Human) requesting a proprietary name review. 

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

We will perform another proprietary name review of GLASSIA 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 the Regulatory Project Manager, Cherie Ward-Peralta, at (301) 827-9170.

Sincerely yours,

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Resources for You

Page Last Updated: 07/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.