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Vaccines, Blood & Biologics

Review Memorandum - Evaluation of Proposed Proprietary Name Rotarix

REVIEW MEMORANDUM

Date: February 25, 2008

To: Laraine S. Henchal, Chair, VVB/DVRPA/OVRR (HFM-478)

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 Rotarix
STN 125265

Recommendation: Acceptable

Executive Summary:

APLB has performed a re-evaluation of the proposed proprietary name, Rotarix, to determine if any new products have been approved since our previous review on August 14, 2006. APLB found that no new products have been approved that would change our previous recommendation. Therefore, APLB recommends that the proposed proprietary name Rotarix 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 Rotarix that would change our previous recommendation.

Recommendation:

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

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

We have considered your proposed proprietary name Rotarix 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 (CDER New and Generic Drug Approvals from August 2006 to February 25, 2008)
http://www.fda.gov/cber/products.htm (CBER approvals from August 2006 to February 21, 2008)

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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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