Re-evaluation of Proposed Proprietary Name - Agriflu, February 24, 2009

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management

Advertising and Promotional Labeling Branch

Review Memorandum

Date: February 24, 2009

To: Anissa Cheung, Committee Chair, DVP/OVRR (HFM-445)
Melissa Baylor, Medical Officer, CRB1/DVRPA/OVRR (HFM-485)

Through: Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB (HFM-602)

From: Lisa L. Stockbridge, Ph.D., CSO, APLB (HFM-602)

Subject: Re-evaluation of proposed proprietary name Agrippal

STN 125297

­­­­­­­­­­­­­­­­Recommendation: Acceptable

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Executive Summary

APLB has performed a re-evaluation of the proposed proprietary name, Agrippal, to determine if any new products have been approved since our previous review on February 14, 2008.  APLB found that no new products have been approved that would change our previous recommendation.  Therefore, APLB recommends that the proposed proprietary name Agrippal 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 was within 90 days of approval.  There were no newly marketed products whose names resembled Agrippal that would change our previous recommendation.

Recommendation

APLB recommends that the proposed proprietary name Agrippal be found acceptable.  No recently approved products whose names resemble Agrippal were found. 

If OVRR accepts our recommendation that the proposed proprietary name Agrippal be found acceptable, please include the following text in your letter to the manufacturer:

We have considered your proposed proprietary name Agrippal in consultation with CBER’s Advertising and Promotional Labeling Branch and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable. 

References Used

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (CDER New and Generic Drug Approvals from February 2008 to February 20, 2009)

http://www.fda.gov/cber/products.htm (CBER approvals from February 2008 to February 6, 2009)

If you have any questions with regards to this review please contact Lisa Stockbridge, Ph.D., Consumer Safety Officer at 301-827-6226.