Navigation Links
FDA Grants Orphan Drug Designation to Ikaria® For Use of Inhaled Nitric Oxide in Pulmonary Arterial Hypertension
Date:1/23/2012

HAMPTON, N.J., Jan. 23, 2012 /PRNewswire/ -- Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the use of inhaled nitric oxide (iNO) with the INOpulse® DS drug-delivery system as a combination product for pulmonary arterial hypertension (PAH). An investigational new drug application (IND) for PAH was submitted to the FDA in November 2011, and the company is pursuing clinical development under this open IND.

Nitric oxide is naturally produced by many cells in the human body, and is known as a "signaling molecule" due to its ability to penetrate cell membranes to deliver a signal to nearby muscles to relax.  When inhaled, nitric oxide selectively relaxes the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of more oxygenated blood to the body. Inhaled nitric oxide is available as INOMAX® (nitric oxide) for inhalation, a vasodilator, which, in conjunction with ventilation and other appropriate agents, treats term and near-term newborns (>34 weeks gestation) with hypoxic respiratory failure associated with evidence of pulmonary hypertension. 

Based on this use, Ikaria is investigating the use of iNO in patients with PAH, which is hypertension in the arteries between the heart and lungs.  The delivery of iNO will be pulsed to synchronize with the patient's breathing pattern through Ikaria's next-generation INOpulse® DS drug-delivery system, which is specially engineered for use in spontaneously breathing patients.  Ikaria's PAH development program, known as IK-7001, will investigate the use of iNO/INOpulse DS as a drug-device combination product.

"Our receipt of orphan drug designation for the use of iNO via the INOpulse in PAH, combined with the IND we submitted last yea
'/>"/>

SOURCE Ikaria, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Grants 510(k) Clearance to Curos® Disinfecting Port Protector
2. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
3. US Patent Office Grants COPAN Invention of Flocked Swabs
4. The European Commission Grants Marketing Authorization for DIFICLIR™ (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
5. Watson Confirms Court Grants Preliminary Injunction Preventing Launch of Generic LOVENOX®
6. FDA Awards NIPTE Potential $35 Million in Grants to Reform Drug Manufacturing Process
7. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
8. Pevion Grants CSL Option Right to its Therapeutic Candida Vaccine
9. Muscular Dystrophy Association Awards $13.7 Million for 40 New Research Grants
10. FDA Grants Fast Track Designation to Bayers Investigational Compound Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone
11. Echo Therapeutics Announces Multiple Patents and Trademark Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... -- Thoratec Corporation (NASDAQ: THOR ), a ... save, support and restore failing hearts, said today it ... Healthcare Conference on Wednesday, September 10. ... will provide an update on the company, beginning at ... Time).   A webcast of the presentation ...
(Date:8/29/2014)... Research and Markets has announced the addition ... report to their offering. Benefiting ... for medical expenses, the Chinese orthopedic instrument market demand ... CAGR of 19.2% during 2009-2013. Trauma products, spine products ... instruments in China , of which ...
(Date:8/29/2014)... DUBLIN , Aug. 29, 2014 Research ... CNS Disorders Drug Pipeline Insight 2014" report to their ... market in US is one of the largest segments of ... an alarming rate, while the available therapies were unable to ... growth in the market for CNS disorder, especially over the ...
Breaking Medicine Technology:China Orthopedic Instrument Industry Report, 2014-2017 2US CNS Disorders Drug Pipeline Insight 2014 2
... MedShape Solutions, Inc, a developer of shape memory orthopedic ... Blair and Tom Hills to the Board of Directors effective ... of experience in the healthcare field, including serving as the ... as the Non-executive Chairman of DJO, Inc., (formerly NYSE-listed sports ...
... Inc. (Pink Sheets: SNDY) is pleased to announce that ... demonstrated at the 95th Annual American College of Surgeons ... During the Breast Ductoscopy for the General Surgeon course, ... hands-on skill stations that will provide the core knowledge ...
Cached Medicine Technology:MedShape Solutions, Inc. Appoints Jack Blair and Tom Hills to Board of Directors; Announces Additions to Management Team 2Solos Endoscopy, Inc.'s MammoView(TM) Product Line to be Demonstrated at the 95th Annual American College of Surgeons Clinical Congress 2
(Date:9/1/2014)... 2014: Daily fruit consumption cuts the risk of cardiovascular ... presented at ESC Congress today by Dr Huaidong Du ... follow-up study of nearly 0.5 million people in the ... ate, the more their risk of CVD declined. , ... and stroke, is the leading cause of death worldwide. ...
(Date:9/1/2014)... (PRWEB) September 01, 2014 As well ... training, Derek is currently pursuing counselor certification in Louisiana. ... advance through the CPI training program as well as ... I have grown both personally and professionally. I ... I am competently able to do so. As ...
(Date:9/1/2014)... September 01, 2014 BCC Research ( ... BLOOD-BRAIN BARRIER TECHNOLOGIES AND GLOBAL MARKETS , the global ... in 2013 and is expected to reach $38.7 million ... $471.5 million by 2019, which is equivalent to 64.9% ... The receptor-mediated transport (RMT) segment is forecasted to grow ...
(Date:9/1/2014)... 2014 In honor of National Take Your Cat ... Emergency & Referral Center of Minnesota (AERC) is offering a few ... their cats. , Many people don’t take their cat to the ... hassle,” but they wouldn’t decide not to take their kid to ... The same goes for pets. Just like people want their loved ...
(Date:9/1/2014)... Registration is now open for the 4th Annual Harmon Meadow ... held on Sunday, September 21, 2014. The event will be ... Secaucus, New Jersey. All proceeds from the race will benefit ... a sense of self, restoring the family unit, and restoring ... General registration is $30 with special pricing for veterans, military ...
Breaking Medicine News(10 mins):Health News:Fruit consumption cuts CVD risk by up to 40 percent 2Health News:Fruit consumption cuts CVD risk by up to 40 percent 3Health News:Narconon Louisiana Announces New Certifications For Staff 2Health News:Global Market for Blood-Brain Barrier (BBB) Technology to Reach $471.5 Million in 2019; Highest CAGR Growth in Latin American Market With 10.5% 2Health News:Global Market for Blood-Brain Barrier (BBB) Technology to Reach $471.5 Million in 2019; Highest CAGR Growth in Latin American Market With 10.5% 3Health News:Animal Emergency & Referral Center of Minnesota Celebrates National Take Your Cat to the Vet Day 2Health News:Animal Emergency & Referral Center of Minnesota Celebrates National Take Your Cat to the Vet Day 3Health News:Hope For The Warriors New Jersey Run to Honor Wounded and Families of the Fallen 2
... abandoned again! WEST PALM BEACH, Fla., April 30 ... civil rights and negligence lawsuit in New York District ... Administration and four other agencies for failure to prevent ... foster parent.Identified in the filing only by their initials, ...
... in daily life: 56 percent of workers use one ... one. Arthritis is a leading cause of work disability, ... physically demanding jobs, and may select jobs that appear ... is a risk factor for pain and musculoskeletal disorders ...
... and others?,What can I do to prevent spreading swine flu? ... the threatening pandemic of "Swine,Flu", where time is of essence ... The Internet News Distribution Channel FEEDZILLA updates news ... "Help stop the,Flu" is available as a widget to be ...
... April 30 The following is being issued by Randall ... Noon, protests will occur on Notre Dame campus ... least one dozen pro-life activists will push baby carriages holding ... the lunch hour on May 1.In addition, life size images ...
... But few options require balancing dangers and benefits, experts ... The risk of developing leukemia from a drug used ... than previously reported, new research shows. , Italian researchers ... an estimated 7.4 people will develop acute leukemia, compared ...
... Shamir Optical Industry Ltd. (Nasdaq: SHMR ) ... technology to the ophthalmic lens market, today announced that it ... chief executive officer, replacing Mr. Eyal Hayardeny who has resigned ... become effective on July 1, 2009.Mr. Netzer currently serves as ...
Cached Medicine News:Health News:Severely Abused Foster Children Sue New York City Child Welfare Agencies After their Failure to Help Them 2Health News:Computer use significantly affected by arthritis 2Health News:Computer use significantly affected by arthritis 3Health News:Leukemia Risk From MS Drug May Be Up 2Health News:Leukemia Risk From MS Drug May Be Up 3Health News:Shamir Optical Industry Ltd. Appoints Amos Netzer as New Chief Executive Officer 2Health News:Shamir Optical Industry Ltd. Appoints Amos Netzer as New Chief Executive Officer 3
The best combination with the Haag-Streit 900 Slitlamps. For examination of the entire fundus, the vitreous and the iridocorneal angle. The classic Goldmann Glass....
This table provides the user with a moderatelypriced, yet fully versatile, electric table which will accept most HAAG-STREIT instruments as well as many of those from other ophthalmic manufacturers....
... The design philosophy of the Uniflex® ... system that could be used for the ... on a closed interlocking intramedullary rod, the ... understanding of the biology of fracture healing ...
... in the Magnes line of biomagnetometer systems, with ... cortical coverage, provides the highest detector density available, ... a wide range of neuronal activity. The Magnes ... configurations and can be equipped with radial magnetometers, ...
Medicine Products: