Navigation Links
FDA Accepts Final Section of NDA Filing for LUCASSIN(R)
Date:6/12/2009

- Priority Review Granted -

LEBANON, N.J., and CLINTON, N.J., June 12 /PRNewswire/ -- Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN(R) (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1. The filing was completed on May 4, 2009, and LUCASSIN has been granted Priority Review as well as Orphan Drug status and Fast Track designation.

HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months.

In September 2008, Ikaria acquired the North American rights to LUCASSIN, including responsibility for manufacturing, distribution, marketing, sales, customer service and post-market development. Those rights will be transferred to Ikaria following marketing approval.

LUCASSIN is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS. Terlipressin was recently approved in France, Ireland, Spain and South Korea for the treatment of patients with HRS Type 1. Terlipressin is not approved by the FDA for use in the U.S.

About Orphan Therapeutics, LLC

Orphan Therapeutics, LLC, is a privately held drug development company dedicated to developing treatments for rare and serious diseases. It was founded in 2003 with the initial purpose to develop and seek U.S. FDA approval for its first product, LUCASSIN(R) (terlipressin), for the treatment of hepatorenal syndrome (HRS) Type 1.

About Ikaria Holdings, Inc.

Ikaria Holdings, Inc. is a biotherapeutics company whose acute care products and therapies address the significant unmet needs of critically ill patients. The company's lead product, INOmax(R) (nitric oxide) for inhalation, is the only FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns, and also is marketed in Canada, Europe, Latin America and Australia. INOmax is approved for marketing in Japan and Mexico. Ikaria is engaged in new and ongoing clinical development of INOmax, carbon monoxide for inhalation and hydrogen sulfide. Ikaria also acquired the North American rights to terlipressin, which currently is under review by the FDA for the treatment of hepatorenal syndrome Type 1. Ikaria is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI, and a manufacturing facility in Port Allen, LA. For more information, please visit www.ikaria.com.


'/>"/>
SOURCE Ikaria Holdings Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
2. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
3. American Stock Exchange Accepts Encisions Plan to Regain Compliance
4. Governor Rendell Accepts National Health Care Reform Pioneer Award
5. FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
6. Lieutenant Governor Catherine Baker Knoll Accepts Women in Government Presidential Leadership Award
7. ev3 Inc. Accepts Resignation of Dr. John Simpson
8. Mike Huckabee Accepts Values Voter Presidential Debate
9. AMEX Accepts Lorus Plan to Meet AMEXs Continued Listing Standards
10. Partnering With MyPyramid: NUTRIKIDS Accepts the Challenge to Help Families Step Up to Healthier Living
11. FDA Accepts Gentas NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance ... greater Dallas, Miami, and Raleigh regions, is organizing an extended charity drive to ... and deadly chromosome abnormality. , After struggling since birth with several health challenges, ...
(Date:10/13/2017)... ... 2017 , ... While it’s often important to take certain medications during the ... Texas, has identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL ... it eliminates the need to turn on a light when taking medication during the ...
(Date:10/13/2017)... Las Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... of 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum ... CBD dose required and providing a CBD form that can be easily incorporated into ...
(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Divoti USA will engrave and process all non-coated stainless ... FDA requirements, which stipulates new criteria regarding medical device manufacture and ... ID jewelry such as Medical ID Bracelets, can rest assured that ... the new FDA requirements . ... Divoti offers this dark mark fiber laser engraving process with ...
(Date:10/11/2017)... , Oct. 11, 2017  BioPharmX Corporation (NYSE ... team that developed an innovative way to use nonlinear ... the delivery of new drugs. ... Clinical Dermatology Conference will show how researchers from BioPharmX ... Harvard Medical School used a suite of imaging techniques ...
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
Breaking Medicine Technology: