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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proposed Proprietary Name Memo, November 16, 2012 - Novoeight

Memorandum                                                                                     Department of Health and Human Services
                                                                                                                                                 Public Health Service


 Food and Drug Administration
Center for Biologics Evaluation and Research

Date:  November 16, 2012

From:  Loan Nguyen, Pharm.D., Regulatory Review Officer
CBER/OCBQ/DCM/APLB (HFM-602)

Through: Lisa Stockbridge, Ph.D., Branch Chief
  CBER/OCBQ/DCM/APLB (HFM-602)

To:  Leigh Pracht, RPM, OBRR/DBA/RPMB (HFM-380)
Stephanie Omokaro, Clinical Reviewer, OBRR/DH/CRB (HFM-392)

Subject: Re-evaluation of proposed proprietary name “NovoEight” [Coagulation Factor VIII (Recombinant)]
BLA STN: 125466/0
Sponsor: Novo Nordisk, Inc

Recommendation: Acceptable
________________________________________________________________________
Executive Summary:
APLB has performed a re-evaluation of the proposed proprietary name, NovoEight, a recombinant coagulation factor VIII, to determine if any new products have been approved since our previous review on March 13, 2012. APLB found that no new products have been approved that would change our previous recommendation.

APLB recommends that the proposed proprietary name NovoEight be found Acceptable at this time.

Background:
On October 15, 2012, Novo Nordisk submitted a request to re-evaluate NovoEight as the proposed proprietary name for their recombinant coagulation factor VIII, as part of their original BLA STN 125466.

NovoEight was found acceptable by the Agency on March 27, 2012 under BB-IND 14059.

The PDUFA action date for this BLA PNR is January 14, 2013.

Recommendation:
Since there are no newly marketed products whose names resembled NovoEight, APLB recommends that the proposed proprietary name, NovoEight, be found acceptable at this time.

APLB will re-review the proprietary name within 90 days of approval to ensure that no new products are approved that could change our current recommendation. The PDUFA action date for this BLA is October 15, 2013.

If you have any questions regarding this review, please contact Loan Nguyen, Pharm.D, Regulatory Review Officer at 301-827-6333.

References:

1. CBER list of Licensed Products ending October 31, 2012 at
http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM149970.pdf
2. Drugs@FDA current through November 15, 2012 at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda
3. Electronic Orange Book current through September 2012 at
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm