
Review of Proposed Proprietary Name InterSol Solution - Intersol, August 7, 2009

 
MEMORANDUM

Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Biologics Evaluation and Research


Date: August 7, 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
Robert A. Sausville
Director, DCM

To:
Salim Haddad, MD, Chairperson, OBRR/DH/LCH
Heather Erdman, CSO, OBRR/DBA/RPMB

Subject:
Review of proposed proprietary name InterSol solution
Platelet Additive Solution
BN080041

Recommendation: InterSol solution proprietary name be found Acceptable with Concerns


Executive Summary:

APLB recommends that the proposed proprietary name InterSol Solution be found Acceptable with Concerns.

Background:

On June 9, 2009, Fenwal, Inc. (Fenwal) submitted a request for review of the proposed name, InterSol Solution, for their Platelet Additive Solution to BN080041. APLB was notified of the proposed proprietary name review on June 5, 2009, when the request was submitted by email and on June 9, 2009, when the request was submitted to the application.

InterSol solution is the proprietary name for this product in the European Union and Fenwal would like to continue to use the same proprietary name in the United States. The proposed name, InterSol Solution, is derived from this solution’s original use as a platelet additive solution used in conjunction with the INTERCEPT pathogen inactivation system marketed in Europe by Cerus Corporation. “Inter” comes from INTERCEPT and “Sol” comes from solution. Fenwal uses “Sol” for other additive solutions, e.g., ADSOL, a red blood cell additive solution in the United States, and T-Sol, a platelet additive solution in Europe.

InterSol is a registered trademark of Fenwal in the United States and is considered a trademark of Fenwal elsewhere in the world.

Analysis Summary for InterSol solution :

The proposed indication for InterSol solution is “a plasma replacement fluid for the storage of platelets using routine blood banking conditions. Platelet products stored in InterSol are transfused to patients with low platelet counts or to decrease bleeding. There is no direct therapeutic effect to be expected from the formulation. The solution should never be infused directly to a patient. InterSol is a platelet storage solution to be used with the AMICUS Separator only.” Fenwal may submit future NDA supplements to seek use with other automated platelet collection technologies or for preparation and storage of platelets derived from whole blood.

The solution is supplied in a 500 mL flexible plastic container with a spikeable membrane port that is protected by a tamper evident twist-off protector. The InterSol solution container is connected to the AMICUS Apheresis Kit with Platelet Additive Solution Connector using the attached spike.
1.False, Misleading, or Fanciful 
The proposed proprietary name is not regarded to be false or misleading. “Inter” means among or between and “sol” is a medical abbreviation for “solution.”
3.Similarity in Spelling or Pronunciation: 

There appears to be a potential for medication errors due to similarity in spelling and pronunciation with proprietary names for other marketed products. Nutricel and InterSol look alike when written. Nutricel is a blood preservative for prolonged storage of red blood cells. However, there will not be a written prescription for either Nutricel or InterSol. Rather, blood collection facilities will order the product(s) that is required by the blood separation device that they use. Therefore, the risk of medication error is low.

Inpersol looks like InterSol when written and the two names sound alike. Inpersol is an irrigating solution for peritoneal dialysis. T he similarity in the names, InterSol and Inpersol, i.e., only one letter difference, does raise concern. However , it is unlikely that Inpersol would be stored in a blood collection facility and because of the difference in indications, the risk of a medication error appears to be low.

5.Similarity in Product Characteristics:

InterSol Solution, Adsol, Optisol, and Nutricel share the product characteristics that they are used in blood collection facilities and they have similar storage temperatures. However, Adsol, Optisol, and Nutricel are blood preservatives for prolonged storage of red blood cells while InterSol Solution is a platelet additive.

The products also differ in that Adsol and Optisol are provided in satellite bags of blood collection bag systems. Nutricel is provided in satellite bags of blood collection bag systems and also as 100 mL bags contained in a foil pouch for use on the Trima automated blood collection system or other automated systems. For this application, InterSol Solution will be provided in a 500 mL flexible plastic container for use on the AMICUS Separator only; however, Fenwal may submit future applications for use of InterSol Solution with other automated platelet collection technologies or for preparation and storage of platelets derived from whole blood. There is a potential for Nutricel and InterSol Solution to be mistakenly interchanged if the blood collection facility uses both products. For example, Nutricel might be connected to the AMICUS Separator in error or InterSol Solution might be used on the Trima collection system. However, the differences in the solution volumes and the indications minimize the risk of a medication error.

The Medical Officer and Chairperson assigned to this application were consulted and they had no concerns regarding the name, InterSol Solution.

Recommendation:

APLB recommends that the proposed proprietary name InterSol Solution be found Acceptable with Concerns.

If OBRR accepts our recommendations that the proposed proprietary name InterSol Solution be found Acceptable with Concerns, please include the following text in your letter to the manufacturer:

We have considered your proposed proprietary name, InterSol Solution, in consultation with CBER’s Advertising and Promotional Labeling Branch and conclude that under 21 CFR Part 201 the proposed proprietary name InterSol Solution is acceptable at this time.

 References:

Facts & Comparisons 4.0 at online.factsandcomparisons.com

Drugs@FDA at  www.accessdata.fda.gov

USPTO Patent Full-Text and Image Database at patft1.uspto.gov

Electronic Orange Book at http://www.fda.gov/cder/ob/default.htm, current through May 2008

RxList at www.rxlist.com

Thomson Micromedex

USAN Dictionary, 2007 Edition at www.uspusan.com

FDA’s Phonetic and Orthographic Computer Analysis

Google

Dogpile

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


Firm name: Fenwal, Inc.

Letter type: Proprietary Name Review

Bcc:
HFM-602 C. Miller 
HFM-602 APLB Proprietary Name File
HFM-602 APLB Chronologic File
HFM-610 R. Sausville
HFM-610 DCM Files

History:
Prepared by: C. Miller 8/4/09
Concur by: E. Ibarra-Pratt 8/7/09
Concur by: R. Sausville 8/7/09
Finalized by: C. Miller 8/7/09

File name: 
APLB eRoom/PNR/PNR InterSol FINAL 07Aug09

Concurrence box:

MailCode or Office Name/Date
HFM-602
HFM-602
HFM-610

