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October 13, 2010 Approval Letter - Gamunex-C

Our STN:   BL 125046/619 

Talecris Biotherapeutics, Inc.
Attention:  Mary Ann Lamb, Ph.D.
8368 U.S. Highway 70 West
Clayton, NC  27520

Dear Dr. Lamb:

We have approved your request to supplement your biologics license application for Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified (IGIV-C) for a new route of administration, subcutaneous administration, for the treatment of Primary Humoral Immunodeficiency.

Under 21 CFR 201.57(f)(2), patient labeling must be reprinted at the end of the package insert and printed in a minimum of 10- point font.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate.  Please provide content of labeling in Structured Product Labeling format.  Please provide 3 original paper copies for all other labels.

In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. 

All promotional claims must be consistent with and not contrary to approved labeling.  You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.

We are waiving the pediatric study requirements for this application for subjects less than 2 years because necessary studies are impossible or highly impracticable.  There are too few children in this age group with this condition to study.

We are deferring submission of your pediatric study for ages 2 to 16 years for this application because this product is ready for approval for use in adults and the pediatric study has not been completed.

Your deferred pediatric study required under 505B(a) of the Federal Food, Drug, and Cosmetic Act is a required postmarketing study.  The status of this postmarketing study must be reported according to 21 CFR 601.70 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act.  This required study is listed below:

1.  Deferred pediatric study under PREA for the treatment of Primary Humoral Immunodeficiency in pediatric patients ages 2 to 16.  The timelines are as follows:

Final Protocol Submission: December 13, 2010
Study Completion Date: August 13, 2013
Final Report Submission: February 13, 2014

Submit final study reports to this BLA.  For administrative purposes, all submissions related to this required pediatric postmarketing study must be clearly designated “Required Pediatric Assessment.”

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

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