Navigation Links
CSL Biotherapies Announces FDA Marketing Approval of its Monovalent Pandemic (H1N1) 2009 Influenza A Vaccine
Date:9/16/2009

CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics licensing application for licensure of its monovalent pandemic (H1N1) 2009 influenza A vaccine for active immunization of persons age 18 years and older against influenza disease caused by the H1N1 virus.

King of Prussia, PA (PRWEB) September 16, 2009 -- CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics licensing application for licensure of its monovalent pandemic (H1N1) 2009 influenza A vaccine for active immunization of persons age 18 years and older against influenza disease caused by the H1N1 virus.

"The FDA's licensure of our H1N1 vaccine is a significant milestone in CSL's efforts to bring an effective pandemic influenza vaccine to the U.S. and Southern hemisphere markets," said Paul Perreault, President, CSL Biotherapies. "We're pleased to have contributed important clinical trial data on this vaccine to regulatory authorities in the United States and Australia. CSL Biotherapies will continue to work closely with the U.S. government to supply pandemic H1N1 vaccine as quickly as possible in order to assist in national efforts to protect the health of Americans."

CSL Biotherapies has an initial contract worth $180 million to deliver bulk H1N1 vaccine antigen to the U.S. Health and Human Services Department (HHS), with an option for filling and packaging services out of CSL's Kankakee, Illinois and Marburg, Germany facilities. These facilities have the capability to produce influenza vaccine in thimerosal-free, prefilled, single-use syringes and in multi-dose vials containing preservative. CSL will supply bulk H1N1 antigen to the U.S. and will formulate that bulk as directed by the federal government. CSL expects to begin delivery of bulk H1N1 antigen to HHS in October, 2009.

About CSL Biotherapies:
The United States headquarters of CSL Biotherapies are located in King of Prussia, PA. Its parent company, CSL Limited, in Melbourne, Australia, has made a $60 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company's Melbourne facility to 40 million doses per season; it is now one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its United States headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally.

The CSL Group, which includes CSL Biotherapies, CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 10,000 employees and operates in 27 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com, or call 1-888-435-8633.

Media Contacts:

Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations
CSL Biotherapies
610-290-7403
484-919-2618 (mobile)

Elizabeth Fisher-Au
Weber-Shandwick
212-445-8111

###

Read the full story at http://www.prweb.com/releases/H1N1_vaccine/Influenza_Vaccine/prweb2893274.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. FindFloridaLawyer.com Announces the Grand Opening of Its Online Attorney Search and Legal Resource Site
2. Telik Announces Presentation and Webcast at UBS Global Life Sciences Conference
3. Cowen Announces Hiring of Don Munoz to Lead Medical Technology Practice; 5th Senior-Level Addition to Cowens Health Care Franchise in 2009
4. Metametrix Announces Availability of Phthalates & Parabens Profile to Help Identify Everyday Exposures
5. Post Acute Medical / Warm Springs Announces Long-Term Contractual Relationship With Gulf States LTAC of New Braunfels
6. ASAP Systems Announces Additional Changes to its Inventory, Warehouse, Stock Tracking, Capital and Fixed Assets Management System and Reseller Program
7. Sono-Tek Announces its Largest Ever Sales of MediCoat Stent Coating Systems to a Leading Global Medical Device Manufacturer
8. Nuvilex, Inc. Announces That Reme-Flu(TM) Will Be Available For Sale On Top-Rated Internet Website
9. Global Med Technologies(R), Inc. Announces Its First EdgeCell Cellular Therapy Software and EdgeLab/HLA Software Sale in North America
10. Accumetrics, Inc. Announces Endotech SPA as Exclusive Distributor for the VerifyNow System in Italy
11. Caraco Pharmaceutical Laboratories, Ltd. Announces Appointment of F. Folsom Bell to Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
CSL Biotherapies Announces FDA Marketing Approval of its Monovalent Pandemic (H1N1) 2009 Influenza A Vaccine 
(Date:10/12/2017)... ... 12, 2017 , ... Leading pediatric oncology experts at Children’s National Health ... Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired ... Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... been named one of Michigan’s 2017 Best and Brightest in Wellness® by Best ... in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 ...
(Date:10/12/2017)... BALTIMORE (PRWEB) , ... October 12, 2017 , ... ... average of $3,296 in property taxes a year. In some states—like New York, ... higher. , By contrast, many overseas retirement havens have extremely low property-tax rates, ...
(Date:10/12/2017)... ... 12, 2017 , ... Farm Forward joins Bon ... leading institutions in announcing the launch of the Leadership Circle , a ... are raised for food. , Founding members of the Leadership Circle also include ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... biologics manufacturer, has expanded its executive staff with the addition of industry sales ... this role, Slott will develop the national distribution and sales network, direct the ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
(Date:10/2/2017)... Oct. 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Software and Consulting, LLC , and named its founder ... based in Tennessee , will operate ... expands EnvoyHealth,s service offerings for health care partners to ... "In an interoperable world, technology ...
(Date:10/2/2017)... COPENHAGEN, Denmark , Oct. 2, 2017 The ... tool in the struggle to reverse the tide of prescription ... plan for regulating their medicine intake and stepping down their ... is set to launch in December 2017; the first 100,000 ... access. Learn more at http://www.rebound-solution.com/ ...
Breaking Medicine Technology: