Printer Friendly
The Free Library
19,573,962 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

APP Pharmaceuticals Announces Plan to Respond to Potential Therapeutic Heparin Shortage in the United States.


SCHAUMBURG, Ill. -- APP Pharmaceuticals, Inc. (Nasdaq:APPX APPX Appendix
APPX Application eXcellence (4GL software development tool) 
) announced today that, in response to FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and hospital concerns about a potential shortage of therapeutic heparin, it will immediately increase manufacturing of the critical therapeutic heparin multi-dose vials. Customers with inquiries may contact APP customer service at 888-386-1300 and will be directed to a "Heparin Hotline" specialist.

APP said that it acquires its Active Pharmaceutical Ingredient, heparin USP USP - unique sales point , from multiple manufacturers, which have been inspected and approved by the FDA. The Company said that its supplier from China has been inspected and approved by both the FDA and China's SFDA SFDA State Food and Drug Administration (China)
SFDA Saudi Food & Drug Authority
, and the supplier is not associated with the Chinese raw material used in the therapeutic heparin under a current recall by another manufacturer.

APP said it has worked closely with the FDA to increase production capacity at its manufacturing facilities. APP is also actively working with suppliers to increase and expedite deliveries, which will enable the Company to produce enough product to meet the entire United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  demand for therapeutic multi-dose vials of heparin.

APP has instituted processes to prevent an imbalance of supply of this critical product needed for life-saving and life-sustaining procedures. In addition, the Company has instituted a direct shipment program to control the distribution and expedite delivery of the products to physicians and patients in urgent need of therapeutic heparin.

Patrick Soon-Shiong, MD, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of APP Pharmaceuticals said, "The potential shortage of heparin is an important public health issue. Heparin is very much in demand and critical to patient-care in both hospitals and dialysis centers. Accordingly, we are marshalling our resources to provide patients with this product which plays such a crucial role in surgery and other life-sustaining procedures. Based on initial analysis of our current inventory of therapeutic heparin, and the plans we are implementing, we are confident we will be able to avert critical shortages."

Tom Silberg, President of APP, stated, "APP manufactures and markets 14 heparin product codes. Prior to this crisis we supplied approximately fifty percent of the U.S. needs for therapeutic heparin. We have actively worked to secure sufficient raw materials and have increased production to respond swiftly to those in need of the product for the entire country."

Heparin is indicated for anticoagulant therapy anticoagulant therapy Hematology The use of anticoagulants to prevent intravascular clot formation, or dissolve clots that have already formed Indications DVT/thrombophlebitis, CAD, TIA/stroke, dysrhythmia, prosthetic heart valve, cancer Monitoring Serial  for patients undergoing surgery, blood transfusions, extracorporeal circulation extracorporeal circulation
n.
Circulation of the blood outside the body, as through a heart-lung machine or artificial kidney.
, dialysis procedures and other settings that require a blood-clotting inhibitor.

About APP Pharmaceuticals

APP is a specialty drug company that develops, manufactures and markets injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
 pharmaceutical products, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company is one of the largest producers of injectables, with more than 100 generic products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit www.APPpharma.com.

Forward-Looking Statement forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 

The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of heparin. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in APP Pharmaceuticals Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2006 filed under the company name Abraxis BioScience, Inc. and other documents it has filed with the Securities and Exchange Commission.

The information contained in this news release is as of the date of this release. APP assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008, Gale Group. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Feb 19, 2008
Words:689
Previous Article:Office-Shadow Adds Impressive Names to Executive Staff and Board.
Next Article:DirectPointe Opens Arizona Office to Support Rapid Growth.
Topics:



Related Articles
Changzhou SPL.
Legislators review FDA inspection policy after heparin adverse reactions.
FDA isolates heparin contaminant; Germany reports AEs from different brand of blood thinner.
Baxter to proceed with recall of remaining heparin sodium vial products.
FDA identifies contaminant in heparin as inspections begin at U.S. border; Braun recalls 23 lots.
Heparin recalled in Europe and Australia as Covidien initiates voluntary recall of syringes in U.S.
EU urges more collaboration after heparin scandal.
Health Canada warns about medical devices with heparin coating.
Heparin manufacturer warned for failing to remove impurities.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles