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:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... expand the ability of Medicare Advantage organizations to deliver medical services via telehealth, ... , “ATA has been advocating for such language for many years. Although ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... company offering education, research and medical media, has launched Contagion® , ... infectious diseases. , As the all-inclusive resource for infectious disease information, Contagion ...
(Date:2/10/2016)... ... February 10, 2016 , ... Intermedix announced on Wednesday ... , an emergency medicine professional association, to support the organization's newly established physician ... Academy of Emergency Medicine, or AAEM, seeks to empower emergency physicians to control ...
(Date:2/10/2016)... ... February 10, 2016 , ... Dr. Peyman Ghasri, ... now offering a variety of comprehensive procedures for facial enhancement. The treatments now ... restoration, lip enhancement and nasal reshaping. , As a result, patients can ...
(Date:2/10/2016)... , ... February 10, 2016 , ... Gout is like ... brings pain that is often severe, with intense swelling and redness. It is triggered ... million people, but older adults are the most susceptible, according to the February 2016 ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... --  Genomic Health, Inc. (Nasdaq: GHDX ) today reported ... December 31, 2015. --> --> ... with $69.1 million in the fourth quarter of 2014, an increase ... percent compared with the same period in the prior year. ... million in the fourth quarter of 2015, an increase of 9 ...
(Date:2/10/2016)... PITTSBURGH , 10 februari 2016 ... detta pressmeddelande får inte distribueras, vare sig ... inga anmälningssedlar kommer att accepteras från eller ... där Erbjudandet, distribution av detta pressmeddelande eller ... mot tillämpliga lagar eller regler eller skulle ...
(Date:2/10/2016)... 2016 Mylan N.V. (NASDAQ, TASE: MYL) today ... ended December 31, 2015. --> ... total revenues of $9.45 billion, up 28% on a ... revenues of $9.43 billion. Excluding the impact of the ... branded generics business (the "EPD Business"), full year adjusted ...
Breaking Medicine Technology: