Re-evaluation Memo - RiaSTAP


MEMORANDUM


Date: 
December 12, 2008 

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

Through:
Ele Ibarra-Pratt, RN, MPH, Branch Chief
CBER/OCBQ/DCM/APLB, HFM-602 

To:
Vasantha Kumar, M.S., Ph.D., RPM, OBRR, DBA, RPMB (HFM-380)
Laura Wood, CMC Committee Chair, OBRR, DH, LBVB (HFM-343)
Nisha Jain, M.D., Medical Officer, OBBR, DH, CRB (HFM-392) 

 Subject:
Re-evalutaion of proposed proprietary name “RIASTAP”
BLA STN: 125317/0
Sponsor: CSL Behring 

Recommendation:
 Acceptable with Concerns 

Executive Summary:

APLB has performed a re-evaluation of the proposed proprietary name, Riastap (REE-uh-stap), Fibrinogen Concentrate (Human) to determine if any new products have been approved since our previous review on October 10, 2008. APLB found that no new products have been approved that would change our previous recommendation. APLB recommends that the proposed proprietary name Riastap be found Acceptable with Concerns .

Background:

APLB re-reviewd the proprietary name to ensure that our review is within 90 days of approval. The PDUFA goal date is January 17, 2009. There are no newly marketed products whose names resembled Riastap.

Recommendation:

APLB recommends that the proposed proprietary name Riastap be found acceptable with concerns at this time. Using tall-man lettering for Riastap (i.e. RIAstaP) is recommended to mitigate potential risk of medication errors with currently marketed products.

References:
1.CBER New BLA, NDA and ANDA approvals lists ending December 12, 2008.
2.CDER New and Generic Drug Approvals: through December 12, 2008 (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
3.Electronic Orange Book: through October, 2008
(http://www.fda.gov/cder/ob)
4.FDA’s Phonetic Orthographic Computer Analysis (accessed December 12, 2008)
5.United States Adopted Names (USAN) - (http://search.ama-assn.org)
