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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Re-evaluation of Proposed Proprietary Name TachoSil - TachoSil, February 19, 2010

 

 

 

MEMORANDUM

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

 


Date:February 19, 2010
FromJean Makie, M.S., R.D., Regulatory Review Officer
Advertising and Promotional Labeling Branch (APLB) (HFM-602)
Division of Case Management (DCM)
Through:Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, (HFM-602)
To:Jie He, RPM, OBRR, DBA, RPMB (HFM-380)
Natalya Ananyeva, Ph.D., CMC Committee Chair, OBRR, DH, LBVB (HFM-343)
Kimberly Lindsey, M.D., Medical Officer, OBBR, DH, CRB (HFM-392)
Subject:Re-evaluation of proposed proprietary name TachoSil
BLA STN: 125351/0
Recommendation:TachoSil proprietary name be found Acceptable

Executive Summary:

APLB has performed a re-evaluation of the proposed proprietary name TachoSil to determine if any new products have been approved since our previous review on September 3, 2009 (please see EDR for complete review memo).  APLB found that no new products have been approved that would change our previous recommendation.  APLB recommends that the proposed proprietary name TachoSil be found Acceptable.

Proposed Proprietary Name Evaluation:

APLB re-reviewed the proprietary name to ensure that our review is within 90 days of approval.  The PDUFA goal date for this original BLA is April 5, 2010. However, the action date is anticipated to be March 29, 2010 ------------------------------------(b)(4)-------------------------------   ---------------------------------------------------------------------------.

Currently, only three other fibrin sealant products are approved for use in the U.S.: TISSEEL, ARTISS, and Evicel. Unlike the patch application of TachoSil, these three products are administered topically by drip or spray by a physician during surgery. There were no newly marketed products whose names resembled TachoSil from a potential look-alike or sound-alike perspective.

Recommendation:

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

References used:

  1. http://www.accessdata.fda.gov/scripts/cder/drugsatfda (CDER New and Generic Drug Approvals); searched 2/17/10
  2. CBER New BLA, NDA and ANDA approvals lists (updated 8/18/09); searched 8/18/09
  3. http://www.accessdata.fda.gov/scripys/cder/ndc/gettradename.cfm; (Current through June 29, 2009); searched 2/17/10
  4. http://www.accessdata.fda.gov/scripys/cder/ndc/gettradename.cfm; (Current through January 29, 2010); searched 2/17/10
  5. http://cdspoca.cder.fda.gov/POCA/search.aspx, searched 2/19/10