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:3/28/2017)... ... ... With expansion and efficiency in mind, Patten Seed Company completed relocation of its ... in Marshallville in 2006, and a bagging and shipping facility has been in place ... Seed operations to the Middle Georgia location from their previous home in Lakeland, Georgia. ...
(Date:3/28/2017)... ... , ... Oily skin is a common and unwelcomed occurrence in people of all ages, genders ... offer to the discussion of dealing with excess skin oil. “Oily skin is a challenge ... that can help remove the oily shine while keeping the skin fresh and clean,” says ...
(Date:3/28/2017)... (PRWEB) , ... March 28, 2017 , ... ... job satisfaction in their profession as their value increases in the healthcare workforce, ... provides resources such as job boards, career fairs, and candidate leads to healthcare ...
(Date:3/28/2017)... ... 28, 2017 , ... Bacteria and fungi are probably not the first ingredients that come to ... the right microorganisms in your diet can actually improve health outcomes. And the good news ... the topic of a new peer-reviewed paper led by Maria Marco, Ph.D. ...
(Date:3/27/2017)... FL (PRWEB) , ... March 27, 2017 , ... ... new patients for clear braces. People who want straight teeth without the extensive ... Invisalign® in Clearwater, FL, without acquiring a referral. A custom-designed series of ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... Calif. , March 27, 2017  Cryoport, Inc. ... that it intends to offer shares of common stock ... registration statement on file with the Securities and Exchange ... and other conditions, and there can be no assurance ... completed, or as to the actual size or terms ...
(Date:3/27/2017)... , March 27, 2017 To mark the end ... , Inc., a leader in digital imaging solutions, will showcase ... convention, held at New York,s Jacob ... Your Vision Month, sponsored by the American Optometric Association, is ... importance of receiving comprehensive eye exams. In recognition of this ...
(Date:3/27/2017)... March 27, 2017  Sophiris Bio Inc. (NASDAQ: ... a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) ... today reported fourth quarter and full year 2016 ... Key Corporate Highlights: Advanced ... Cancer. During 2016, the Company reported successful results ...
Breaking Medicine Technology: