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
|Recommendation:||Acceptable with Concerns|
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.
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.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda (CDER New and Generic Drug Approvals from August 2009 to October 7, 2009)
If you have any questions with regards to this review please contact Catherine Miller, Consumer Safety Officer at 301-827-3028.