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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Re-evaluation Memo, February 14, 2011 - Corifact

Date:       February 14, 2011

From:       Michael Brony, Pharm.D., Regulatory Review Officer
                Advertising and Promotional Labeling Branch (APLB) (HFM-602)
                Division of Case Management

Through:   Lisa L. Stockbridge, Ph.D., Branch Chief
                Advertising and Promotional Labeling Branch (APLB) (HFM-602)
                Division of Case Management

To:           Nannette Cagungun, OBRR/DBA
                Daniela Vanco, MD, Medical Officer, OBRR/DH/CRB

Subject:    Re-evaluation of proposed proprietary name CORIFACT BLA -125385

Recommendation:      Acceptable 
 


Executive Summary:
APLB performed a re-evaluation of the proposed proprietary name, Corifact, (Factor XIII Concentrate (Human)), to determine if any new products have been approved since our previous review on November 9, 2010. We found that no new products have been approved that would change our previous recommendation. Thus, APLB recommends that the proposed proprietary name Corifact be found Acceptable.

Background:
APLB provides this re-evaluation of the proprietary name to ensure that our review is within 90 days of approval.  We find that there are no newly marketed products whose names resemble Corifact.

Recommendation:
APLB recommends that the proposed proprietary name, Corifact, be found acceptable at this time.

If you have any questions with regards to this review please contact Michael Brony, Pharm.D., Consumer Safety Officer at 301-827-6342.

References:
CBER New BLA, NDA and ANDA approvals lists ending January 31, 2011.

http://www.labeldataplus.com/
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
http://www.google.com