Navigation Links
FDA Approves First Additive Solution for Platelet Storage Up to 5 Days
Date:12/10/2009

SILVER SPRING, Md., Dec. 10 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved InterSol, the first solution approved to replace a portion of plasma used when storing platelets for up to five days, allowing some of the donor plasma to be used for other purposes.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

In the United States, platelets, which are blood components that help with blood clotting, have been stored in donor plasma. About 65% of that plasma is replaced with the InterSol platelet additive solution.

Platelets are used to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, after major trauma, during or after surgery, and in individuals who do not produce platelets. InterSol solution does not have a therapeutic effect by itself but acts to provide nutrients and an appropriate environment in which to store platelets.

"The approval of InterSol is a significant step in the development and marketing of novel processes for the storage of platelets," said Karen Midthun, MD, acting director of FDA's Center for Biologics Evaluation and Research.

The InterSol platelet additive solution is an aqueous solution of various salt components. It replaces a proportion of plasma in the storage of platelets collected by an automated instrument.

InterSol solution is manufactured by Fenwal Inc., Lake Zurich, IL.


Draft: OBRR, 10/19/09
Edits: W. J. Gardner, 10/20/09
Edits: D. Bartell, 10/20/09
Edits: L. McNeill, 10/20/09
Revised: D. Bartell, 10/20/09
Edits: S. Burgess, 10/26/09
Edits: G. Michaud, 10/26/09
CBER Clearance: D. Maloney, 10/27/09
Edits/Clearance: OPA, 10/30/09
Comments: M. Robinson, HHS, 11/27/09
Edits: W. Gardner, 11/30/09
Edits: H. Salim, 11/30/09
Edits and CBER Clearance: B. Yetter, 12/1/09
Edits: N. Jain, 12/1/09
Review/Clearance: G. Michaud, 12/1/09

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. U.S. Approves New Stem Cell Lines for Publicly Funded Research
2. State Approves Plans For Kidney Transplants At Advocate Christ Medical Center
3. FDA Approves New Treatment for Chronic Lymphocytic Leukemia
4. CMS Approves Press Ganey as a Qualified Home Health Care CAHPS Survey Vendor
5. FDA Approves PRE-PEN Penicillin Allergy Test
6. FDA Approves Donor Screening Test for Antibodies to HIV
7. ClearWay Minnesota(SM) Board Approves New Officers
8. FDA Approves Vaccines for 2009 H1N1 Influenza Virus
9. FDA Approves 4 Swine Flu Vaccines
10. FDA Approves Valcyte(R) (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants
11. FDA Approves XYZAL(R) For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... ... February 24, 2017 , ... Yisrayl Hawkins, Pastor and Overseer ... Prophecy concerning this present generation. Yisrayl makes an astounding statement when he says ... He explains that the Bible details the current times so plainly that anyone should ...
(Date:2/24/2017)... ... February 24, 2017 , ... Rosica Communications, ... thought leadership , media relations, social media, content marketing and SEO, is ... powered through Act-On, an intuitive marketing automation platform. , Rosica will now offer ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... ... Department of Justice jointly issued a letter to withdraw previous guidance ... with their gender identity. The guidance issued in May 2016 by the Obama ...
(Date:2/23/2017)... ... ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased to announce KLS Martin ... supporter of the event. , "We are pleased that KLS Martin is joining us ... ACPA President. "KLS Martin has a long track record of support of the American ...
(Date:2/23/2017)... ... February 23, 2017 , ... EBSCO ... the National Institute for Health and Care Excellence (NICE) framework. The ... National Health Service (NHS) to search, order and purchase medical and healthcare-related content ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... , Feb. 23, 2017 Visiomed, the ... services since 1997, is changing the landscape of ... providing patients with pro-active, custom-made solutions. Recognizing the ... instant and affordable healthcare without walls, Visiomed has ... devices developed with healthcare professionals that is empowering ...
(Date:2/23/2017)... 23, 2017 ITL Limited, ( ASX: ITD ), an ... the half year ended 31 December 2016 compared with the previous ... can be viewed here . Highlights ... up 104%) Earnings per share of 2.2 cents ... $17.5m (Dec 2015: $15.7m; up 11%) Profit before ...
(Date:2/23/2017)... Research and Markets has announced the addition of the ... their offering. ... The latest research Fibromyalgia Drugs Price Analysis and Strategies - 2016, ... The research answers the following questions: ... clinical attributes? How are they positioned in the Global Fibromyalgia market? ...
Breaking Medicine Technology: