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 he
'/>"/>

SOURCE Ikaria Holdings Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:4/26/2015)... FL (PRWEB) April 26, 2015 A ... pieces of medical equipment from hospitals, surgery centers and ... of equipment will be sold including radiology, surgery, endoscopy, ... live auction will take place Tuesday, April 28th starting ... Lauderdale warehouse located at 5025 North Hiatus Rd., Sunrise, ...
(Date:4/26/2015)... New York (PRWEB) April 26, 2015 ... popular events of the season and will include a ... like purses, totes, collectibles, herbal soaps and incense, chimes, ... While browsing this year’s exciting and unique collection of ... their afternoon with Jim Martocci and the Jimmie Jazz ...
(Date:4/26/2015)... 26, 2015 Forbes Living is ... is one which is synonymous with clean beaches, sparkling office ... education are major economic influencers in the city on the ... talk show are pleased to announce the show will be ... at 3:00 PM PDT. Tune in to find out what ...
(Date:4/26/2015)... MidSouth Pain Treatment Center has ... Pain Treatment Center is a comprehensive pain management center ... Jackson, two ambulatory surgery centers in Germantown and Southaven, ... locations. , Dr. Michael Steuer , founder of ... help people, and when I discovered that I could ...
(Date:4/25/2015)... 2015 Diversified Communications has announced ... event. The Integrative Healthcare Symposium Canada, as it’s ... at the Sheraton Parkway Toronto North in Ontario. ... of the most anticipated events of the year ... program. The event aims to gather multi-disciplined practitioners ...
Breaking Medicine News(10 mins):Health News:Centurion Service Group to Auction off 1,200 Lots of Medical Equipment 2Health News:It’s Coming! The 5th Annual Tulip Festival & Mother’s Day Celebration at Honor's Haven Resort & Spa! 2Health News:Forbes Living TV Will Air in San Diego, California 2Health News:Growing Pains for MidSouth Pain Treatment Center 2Health News:Integrative Healthcare Event launching in Canada 2
... 5 in the February 2008 edition (Volume 6, Issue ... team found that the hypertension drugs diltiazem and verapamil ... with the conditions Gaucher disease, -mannosidosis, and type IIIA ... reprogramming the innate protein homeostasis machinery of the cell ...
... WASHINGTON, Feb. 4 "Congress must reject,President Bush,s Fiscal ... needs of the over 1.1 million people living with ... Director of The AIDS,Institute. "Most of the people who ... are very poor and from minority communities.,As the richest ...
... largest of its kind , , MONDAY, Feb. 4 (HealthDay News) ... link between the measles, mumps and rubella (MMR) vaccine and ... theirs was the third and largest study that has looked ... has failed to find one. , "I think it,s fabulous ...
... Gilbert Hospital is,celebrating its second anniversary. Gilbert,s first ... more than 93,000 patients and has a,staff exceeding 350. ... room wait times of less than 31 minutes, Gilbert,Hospital ... this pledge,more than 98.5 percent of the time. "There ...
... Feb. 4 - President George W.,Bush today submitted ... 2009.,In response Bruce Roberts, RPh, executive vice president ... issued the following,statement:, "President Bush,s efforts to ... health care, and even more specifically the Medicare,and ...
... a consulting firm,dedicated exclusively to improving the pharmacy ... the recent,introduction of the ARMSRx E-Audit, their upgraded ... often overlooked piece of the prescription,benefits package. The ... of opportunities in which errors can occur. Fraud, ...
Cached Medicine News:Health News:Scripps scientists find calcium channel blockers help normalize lysosomal storage disease cells 2Health News:Scripps scientists find calcium channel blockers help normalize lysosomal storage disease cells 3Health News:Scripps scientists find calcium channel blockers help normalize lysosomal storage disease cells 4Health News:President's FY09 Budget - A Disaster for Domestic AIDS: Congress Must Fund Critical Healthcare Priorities 2Health News:President's FY09 Budget - A Disaster for Domestic AIDS: Congress Must Fund Critical Healthcare Priorities 3Health News:Another Study Finds No Link Between MMR Vaccine and Autism 2Health News:Another Study Finds No Link Between MMR Vaccine and Autism 3Health News:Gilbert Hospital Turns Two 2Health News:NCPA Statement in Response to President Bush's FY 2009 Budget Proposal 2Health News:ARMSRx Tackles the New Rx Addiction -- Pharmacy Benefit Audits 2
(Date:4/24/2015)... N.C. , April 24, 2015  New ... ability of consumers to educate themselves about products ... the tools and techniques available to market researchers ... the changing consumer marketplace, it,s imperative that organizations ... to better identify market opportunities, niches and growth ...
(Date:4/24/2015)... MARLBOROUGH, Mass. , April 24, 2015 Boston ... in the Deutsche Bank 40 th Annual Healthcare Conference ... Dan Brennan , executive vice president and chief ... Relations, will participate in a 35-minute question and answer session ... a.m. ET. A live webcast of the presentation ...
(Date:4/24/2015)... , April 24, 2015  Novartis Pharmaceuticals Corporation (NPC) ... second year in a row on the annual DiversityInc Top ... its 2015 Top 50 Companies for Diversity on April 23 ... . NPC also ranked second on the DiversityInc Top ... 10 Companies for Employee Resource Groups list. ...
Breaking Medicine Technology:Pharmaceutical Industry Using New Technologies to Adjust Their Marketing and Research Approaches for Consumers 2Boston Scientific To Participate In The Deutsche Bank 40th Annual Healthcare Conference 2Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 2Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 3Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 4
... 2011 /PRNewswire-Asia-FirstCall/ -- American Oriental Bioengineering, Inc. (NYSE: ... company dedicated to improving health through the development, manufacture ... over the counter ("OTC") products, today announced that it ... financial results on Monday, March 14, 2011, after the ...
... China, March 4, 2011 /PRNewswire-Asia-FirstCall/ -- ... WKBT ) ("Weikang" or the "Company"), a ... (TCM), Western prescription and OTC pharmaceuticals and other health ... today announced that the Company will be presenting at ...
Cached Medicine Technology:American Oriental Bioengineering to Announce Fourth Quarter and Full Year 2010 Financial Results on March 14, 2011 2Weikang Bio-Technology to Present at Rodman & Renshaw Annual China Investment Conference 2
... Vitamin D kit is an enzymeimmunoassay for ... hydroxylated metabolites in serum or plasma. Calibrators, ... labelled 25-OH D. The diluted samples are ... with a highly specific sheep 25-OH D ...
... for the control of glucose metabolism. It ... of Langerhans as the precursor, proinsulin, which is ... are secreted in equimolar amounts into the portal ... of two polypeptide chains, the A-chain and B-chain ...
... is an integral part of the enzymatic ... II as well as the degradation of ... ACE is primarily located in endothelial cells. ... parameter for sarcoidosis and myocardial infarction but ...
... Retinol binding Proetin (RBP) is small (21kD) ... complex with pre-albumin in blood but loses ... been deliverd to the target cells. The ... the glomerulus and catabolized in the,renal tubules ...
Medicine Products: