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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 InterSol Solution Memorandum - Intersol, October 13, 2009

 

 

 

MEMORANDUM

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


Date:October 13, 2009
From:Catherine Miller, Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Division of Case Management (DCM)
Through:Ele Ibarra-Pratt, RN, MPH
Branch Chief, APLB
To:Salim Haddad, MD, Chairperson, OBRR/DH/LCH
Heather Erdman, CSO, OBRR/DBA/RPMB
Subject:Re-evaluation of proposed proprietary name InterSol Solution
Platelet Additive Solution
BN080041
Recommendation:Acceptable with Concerns

Executive Summary:
APLB has performed a re-evaluation of the proposed proprietary name, InterSol Solution, to determine if any new products have been approved since our previous review on August 7, 2009. APLB found that no new products have been approved that would change our previous recommendation. APLB recommends that the proposed proprietary name, InterSol Solution, be found Acceptable with Concerns.

Proposed Proprietary Name Evaluation:

APLB re-reviewed the proprietary name to ensure that our review was within 90 days of approval. The PDUFA action date is December 12, 2009. There were no newly marketed products whose names resembled InterSol Solution.

Recommendation:

APLB recommends that the proposed proprietary name InterSol Solution be found Acceptable with Concerns. No recently approved products whose names resemble InterSol Solution were found.

References used:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda (CDER New and Generic Drug Approvals from August 2009 to October 7, 2009)
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear

If you have any questions with regards to this review please contact Catherine Miller, Consumer Safety Officer at 301-827-3028.