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:3/24/2017)... ... ... The iaedp Foundation, the premier provider of educational programs and training standards for ... spectrum of disordered eating, announced today that the 2017 Symposium set a new attendance ... several countries converged on the Green Valley Resort in Las Vegas. , “We ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... Assili, announce that they are now offering treatments for sleep apnea and TMJ ... dental offices. Sleep apnea , specifically the obstructive type, is increasingly being ...
(Date:3/24/2017)... ... 24, 2017 , ... Empower Brokerage, located in Southlake, Texas, ... programs. , In February, 2017, Empower Brokerage introduced their new “Performance Partners” program ... to teach how to maximize their sales efforts, as well as how to ...
(Date:3/24/2017)... ... March 24, 2017 , ... “The Communion ... real people of God in congregations across the United States. “The Communion ... ordained in 1964 who has served congregations in seven states throughout his long ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... services to their communities, 16 more public health departments have been awarded national ... bring another 4.5 million people into the expanding network of communities across the ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... ShangPharma, a leading life science ... development and discovery services, technology, and investment ... today the intent for a strategic corporate ... the Contract Research Organizations (CRO) and Contract ... entities include ChemPartner Shanghai, ChemPartner Fengxian, ChemPartner ...
(Date:3/24/2017)... 24, 2017 Research and Markets has announced ... Diagnostics, 2017 - 2035" report to their offering. ... The Deep Learning: Drug Discovery ... outlook of the growing market of deep learning solutions within the ... algorithms have emerged as a novel solution to generate relevant insights ...
(Date:3/24/2017)... , Mar 24, 2017 Research and Markets ... Global Strategic Business Report" report to their offering. ... The report provides separate comprehensive analytics for ... Europe , Asia-Pacific , ... are provided for the period 2015 through 2022. Also, a six-year historic ...
Breaking Medicine Technology: