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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memo - Re-Evaluation of Proposed Proprietary Name - RECOTHROM

M E M O R A N D U M

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Date: December 3, 2007
From: Maryann R. Gallagher, Consumer Safety Officer
Advertising and Promotional Labeling Branch, HFM-602
Division of Case Management
Through: Ele Ibarra-Pratt, Branch Chief, APLB, HFM-602
To: Roman Drews, OBRR/DH/LH, HFM-392
Mark Shields, OBRR/DBA/RPMB, HFM-380
Subject: Re-evaluation of proposed proprietary name RECOTHROMT (Recombinant Human Thrombin)
BLA 125248/0.4
Recommendation: ACCEPTABLE

Executive Summary:

APLB has performed a re-evaluation of the proposed proprietary name RECOTHROM, to determine if any new products have been approved since our previous review on June 13, 2007 (memo attached). APLB found that no new products have been approved that would change our previous recommendation. APLB recommends that the proposed proprietary name RECOTHROM be found Acceptable.

Proposed Proprietary Name Evaluation:

APLB re-reviewed the proprietary name because substantial time had passed since our last review and to ensure that our review is within 90 days of approval. The PDUFA goal date is January 17, 2007. There were no newly marketed products whose names resembled RECOTHROM.

Recommendation:

APLB recommends that the proposed proprietary name RECOTHROM be found acceptable at this time. No recently approved products whose names resemble RECOTHROM were found.

References used:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (CDER and Biologic Approvals through October 31, 2007)

http://www.fda.gov/cber/products/htm (CBER New BLA, 510(k) Devices, NDA and PMA approvals lists through September 28, 2007).

 

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