Navigation Links
Octapharma USA Submits BLA for octaplasLG®, a Therapy Targeting Adverse Transfusion Events
Date:2/27/2012

HOBOKEN, N.J., Feb. 27, 2012  /PRNewswire/ -- Octapharma USA has submitted its Biological License Application (BLA) for octaplasLG® to the U.S. Food and Drug Administration (FDA) with the goal of expanding its U.S. product portfolio by the fourth quarter of 2012.

The FDA will evaluate the octaplasLG® BLA for an indication of managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors. The application also seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP), a blood disorder that causes clot formation in small blood vessels. The product features solvent/detergent inactivation against enveloped viruses and immune neutralization against non-enveloped viruses.

"We look forward to bringing octaplasLG® to the U.S. medical community," said Octapharma USA President Flemming Nielsen. "This trusted therapy has been successfully used to treat patients for more than 15 years in Europe and over 30 countries worldwide."

Octapharma USA has started to lay the groundwork for the introduction of octaplasLG®, coordinating a physician advisory board meeting in late 2011 with leading treatment professionals in transfusion medicine, hematology and surgery.

About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for nearly 30 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat primary immune deficiencies, and Octapharma's Albumin (human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® (Von Willebrand Factor/Coagulation Factor VIII Complex [human]) received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of certain types of Von Willebrand Disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J.  Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com or www.wilateusa.com.

Forward-looking statements
This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.


'/>"/>
SOURCE Octapharma USA
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Octapharma USA Appoints Global Biopharmaceutical Executive David E. Holliday as Vice President of Commercial Development
2. Octapharma Announces octagam® 5% Again Available for U.S. Purchase
3. FDA Approves U.S. Market Return for octagam® Following Octapharmas Implementation of Enhanced Safety Measures
4. Octapharma USA to Participate in Important Medical Meetings at AABB, NHF, ASHP and ASH
5. Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing Surgical Bleeding in Type 3 von Willebrand Disease Patients
6. Octapharma USA Sponsors International Advisory Board for Evaluating Treatment of Patients with von Willebrand Disease
7. Octapharma Targets Primary Immune Deficiency Research With Grant for The Mount Sinai Medical Center
8. Octapharma Clinical Trial Begins in the U.S. and Germany Treating Hemophilia A Patients with First Recombinant Factor VIII Derived from a Human Cell-Line
9. Octapharma Accepting Applications for Research Grants Focused on Human Protein Therapies
10. Octapharma USA Launches Web Resource for von Willebrand Disease Healthcare Professionals and Patients
11. FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USAs New Therapy for Common Inherited Bleeding Disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... 2017  BioPharmX Corporation (NYSE MKT: BPMX) researchers were ... innovative way to use nonlinear optical imaging to confirm ... drugs. A ... show how researchers from BioPharmX and the Wellman Center ... a suite of imaging techniques in what is called ...
(Date:10/11/2017)... Texas , Oct. 11, 2017  True ... services, has amplified its effort during National Breast ... about hereditary cancer risks. ... of Clinical Oncology calculated that more than 10 ... have inherited mutations in BRCA1 or BRCA2 and have ...
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... for healthcare compliance program management, will showcase a range of technology and learning ... Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 at ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company ... of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every ... meet the highest standard. , These products are also: Gluten Free, Non-GMO, ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... Malvern, PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best ... New York City on October 11, 2017. , The annual award competition recognizes editorial ...
Breaking Medicine News(10 mins):