Date: July 7, 2009
To: Helen Gemignani, Committee Chair, OVRR/DVRPA/CMC3 (HFM-478)
Robin Levis, Biologist, OVRR/DVP (HFM-451)
Through: Ele Ibarra-Pratt, RN , MPH, Branch Chief, OCBQ/DCM/APLB (HFM-602)
From: Lisa L. Stockbridge, Ph.D., CSO, OCBQ/DCM/APLB (HFM-602)
Subject: Re-evaluation of proposed proprietary name Cervarix STN 125259
The Advertising and Promotional Labeling Branch (APLB) has performed a re-evaluation of the proposed proprietary name, Cervarix, to determine if any new products have been approved since our initial proprietary name review (PNR) dated January 3, 2006. APLB found that no new products have been approved that would change our previous recommendation. Therefore, APLB recommends that the proposed proprietary name, Cervarix, be found ACCEPTABLE .
Proposed Proprietary Name Evaluation
Reference is made to the January 3, 2006, PNR in which APLB found the name, Cervarix, to be acceptable for use. Although similar in sound and spelling, Serevent (an inhaled bronchodilator) was considered to create only minimal cause for confusion because of the difference in dosage form to Cervarix, which is an intramuscular injectable vaccine. APLB re-reviewed the proprietary name because substantial time had passed since the initial PNR review and to ensure that our review was within 90 days of approval.
There are no newly marketed products whose names resemble Cervarix. However, there is another injectable drug product that could cause confusion in sound and spelling: Cerebyx. Cerebyx is injectable fosphenytoin indicated for the parenteral treatment of seizures, particularly generalized convulsive status epilepticus, and for the prevention and treatment of seizures occurring during neurosurgery. While there is a potential for confusion, Cerebyx is most often used in a hospital surgical setting, whereas Cervarix would most often be used in the doctor’s office or clinic. Therefore, APLB maintains its recommendation of ACCEPTABLE .
If OVRR accepts our recommendation that the proposed proprietary name Cervarix be found acceptable, please include the following text in your letter to the manufacturer:
We have considered your proposed proprietary name Cervarix in consultation with CBER’s Advertising and Promotional Labeling Branch and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable at this time.
http://dailymed.nlm.nih.gov/dailymed (accessed July 7, 2009)
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (CDER New and Generic Drug; accessed July 7, 2009)
http://www.fda.gov/BiologicsBloodVaccines (CBER approvals; accessed July 2009)
If you have any questions with regards to this review please contact Lisa Stockbridge, Ph.D., Consumer Safety Officer at 301-827-6226.