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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The Visiting ... Day Market. Featuring a collection of specialty vendors and unique items from across the ... and quality-focused health and wellness services offered by the VNA. The boutique will ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... has recently contributed a medical article to the newly revamped Cosmetic Town ... article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... , Oct. 12, 2017   Divoti USA ... up to the standard of the latest FDA requirements, which stipulates ... Anyone in need of Medical ID jewelry such as ... Jewelry are engraved in terms of the new FDA ... Divoti offers this ...
(Date:10/11/2017)...  Caris Life Sciences ® , a leading innovator ... precision medicine, today announced that St. Jude Medical Center,s ... (POA) as its 17 th member. Through participation ... Cancer Institute will help develop standards of care and ... making cancer treatment more precise and effective. ...
(Date:10/10/2017)... 10, 2017  NDS received FDA 510(k) clearance in May 2017 ... display stand specifically designed for endoscopy environments. An innovative secondary monitor ... clinical solution to support the improvement of patient outcomes, procedural efficiency, ... ... ...
Breaking Medicine Technology: