


Information Request Memo, December 1, 2011 - Hyqvia




 

 
Food and Drug Administration
Center for Biologics Evaluation and Research

Memorandum

Date: 11.29.2011

From: Jennifer L. Reed, Ph.D.; CBER/OBRR/DH/LPD
HFM-345; 301-496-0625

To: File for BLA 125402/0

Reference: IND 13840; STN BL 125105 (Immune Globulin Intravenous (Human), 10% 
Solution; Gammagard Liquid); NDA 21-859 (hyaluronidase human injection, Hylenex)

Through: Dorothy Scott, M.D.; CBER/OBRR/DH/LPD; HFM-345; 301-827-3016

Cc: Mark Shields; CBER/OBRR/DBA; HFM-380; 301-827-6173

Subject:  Product related IR

Product: Immune Globulin Infusion (Human), 10% with Recombinant Human 
Hyaluronidase: HYQVIA

Submission Date: June 30, 2011

Manufacturer: Baxter Healthcare Corporation

Information Request:

The following letter-ready comment can be communicated to the Sponsor:

1) Please clarify whether the potency limits for rHuPH20 at the end of shelf 
life are different from the potency release specification.  What is the target 
potency for rHuPH20 at fill?
 

    
 