Re-evaluation of Proposed Proprietary Name - Wilate, November 9, 2009


Date:
November 9, 2009 

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:
Pauline Cottrell, RPM, OBRR, DBA, RPMB (HFM-380)
Timothy Lee, Committee Chair, OBRR, DH, LBVB (HFM-392)
Hon-Sum Ko, Medical Officer, OBRR, DH, CRB (HFM-392) 

Subject:
Re-evaluation of proposed proprietary name “Wilate” 

BLA STN:
125251/0 

Sponsor:
Octapharma 

Recommendation:
Acceptable 

       


 

Executive Summary:

APLB has performed a re-evaluation of the proposed proprietary name, Wilate, Coagulation Factor VIII/von Willebrand Factor Complex (Human), to determine if any new products have been approved since our previous review on July 10, 2007. APLB found that no new products have been approved that would change our previous recommendation. APLB recommends that the proposed proprietary name Wilate be found Acceptable.

Background:

APLB re-reviewed the proprietary name to ensure that our review is within 90 days of approval. The PDUFA goal date for this product is December 4, 2009. There are no newly marketed products whose names resembled Wilate.

Recommendation:

APLB recommends that the proposed proprietary name, Wilate, be found acceptable at this time.

If you have any questions with regards to this review, please contact Loan Nguyen, Pharm.D, Regulatory Review Officer at 301-827-3028.

References:
1.CBER New BLA, NDA and ANDA approvals lists ending November 2009.
2.CDER New and Generic Drug Approvals: through November 9, 2009
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
3.Electronic Orange Book: through September , 2009
(http://www.fda.gov/cder/ob) 
4.FDA’s Phonetic Orthographic Computer Analysis (accessed November 9, 2009)
	