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

r, speaks to the solid progress of our late-stage pipeline," stated Daniel Tasse, Chairman and CEO of Ikaria.  "We're delighted to have PAH and bronchopulmonary dysplasia as additional indications under investigation for iNO, and also are planning its investigation with the INOpulse DS in chronic obstructive pulmonary disease."

Orphan drug designation is reserved for rare diseases or disorders that affect fewer than 200,000 people in the United States. PAH affects fewer than 200,000 Americans. This designation offers the sponsor tax credits on certain development costs, a waiver of the new drug application (NDA) application user fee, and an exclusivity period of seven years following marketing approval.  In addition to the seven-year marketing exclusivity period granted under the orphan drug designation, the INOpulse DS drug-delivery system would be further protected by developing a portfolio of patents, the last of which expires no earlier than 2029.

About INOMAX®

INOMAX® is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration. 

Please see attached prescribing information.  For addi
'/>"/>

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:4/20/2015)... , April 20, 2015  Sigma-Aldrich Corporation ... Corporate Responsibility (CR) Magazine,s list of the 100 ... on outstanding corporate responsibility performance.  Sigma-Aldrich ranked fifth, ... appearance on the list. "We are ... corporate responsibility efforts and we are extremely pleased ...
(Date:4/20/2015)... The preclinical contract research organization Absorption Systems ... safety testing of medical devices, announces that its Chief Scientist, ... " Drug Transporters in ADME: From the Bench to the ... title of Dr. Hidalgo,s talk is "Modern Tools for the ... Tools of the Future." The workshop, organized jointly ...
(Date:4/20/2015)...  Ameritox,s Ingenuity Health, a leading provider of monitoring ... at the National Council of Behavioral Health annual conference ... nearly 25 percent of the samples collected from patients ... prescribed antipsychotic medication. ... Medication nonadherence ...
Breaking Medicine Technology:Sigma-Aldrich Named to CR Magazine's 100 Best Corporate Citizens List 2Absorption Systems Chief Scientist Ismael Hidalgo to Present at International Workshop on Drug Transporters 2Ingenuity Health Research Flags Potentially High Rate of Medication Nonadherence Among Those with Serious Mental Illness 2Ingenuity Health Research Flags Potentially High Rate of Medication Nonadherence Among Those with Serious Mental Illness 3
... FOREST, Ill., April 11, 2011 PharMEDium Healthcare Corporation ... of Anesthesiologists (ASA), as a part of a new ... practice management companies. David N. Jonas, PharMEDium ... ASA,s efforts to advance the anesthesiology field through leadership, ...
... In response to Thursday,s Medicare Payment Advisory ... substantially higher levels of advanced diagnostic imaging services ... approval before being able to provide those services, ... instead look to existing clinical decision support tools ...
Cached Medicine Technology:PharMEDium Becomes a Corporate Supporter of the American Society of Anesthesiologists (ASA) 2Healthcare Providers, Technology Experts Call for Use of Existing Decision Support Tools to Promote Diagnostic Imaging Appropriate Use 2Healthcare Providers, Technology Experts Call for Use of Existing Decision Support Tools to Promote Diagnostic Imaging Appropriate Use 3
(Date:4/21/2015)... 2015 The Northeast Football Clinic (NEFC) ... Academy prep school in Byfield, MA. Applications are being ... boys entering grades 6-12. , The outstanding professional, college, ... fall coaching. , Offensive and defensive linemen ... these the most unsung positions on the field, the ...
(Date:4/21/2015)... Dr. Zain Kadri, a Beverly Hills plastic ... takes a close look at the rise of plastic surgery ... on both Dr. Kadri’s website and RedOrbit , is ... Age of the Selfie.” According to Dr. Kadri, who offers ... variety of A-list patients, the trend of taking selfies has ...
(Date:4/21/2015)... Sunnyvale, CA (PRWEB) April 21, 2015 ... research solutions for biopharmaceutical development, today announced that the ... at the University of Ottawa has acquired a Freeslate ... and Screening Pressure Reactor (SPR) to accelerate ... the High-Throughput Experimentation Facility where they will be available ...
(Date:4/21/2015)... Spring and summer are popular seasons to ... for the holidays or simply taking vacations. Deciding what ... can be a difficult choice. Pet-friendly accommodations are gaining ... becoming a more common option. Royal Flush Havanese ... pet-friendly accommodations a positive experience. , 1.) Firstly, it ...
(Date:4/21/2015)... This program provides physical therapists, ... occupational therapist assistants, teachers, and other school based ... children across the autism spectrum succeed in the ... Inc. , Used throughout the United ... yoga curriculum addresses learning and behavior issues across ...
Breaking Medicine News(10 mins):Health News:US Sports Camps and The Northeast Football Clinic Announce 2015 Lineman/Linebacker Clinic Schedule 2Health News:Beverly Hills Plastic Surgery Expert Dr. Zain Kadri Releases Thought-Provoking New Infographic 2Health News:University of Ottawa Selects Freeslate Reaction Screening System to Support High-Throughput Research at the Centre for Catalysis Research and Innovation 2Health News:University of Ottawa Selects Freeslate Reaction Screening System to Support High-Throughput Research at the Centre for Catalysis Research and Innovation 3Health News:Royal Flush Havanese Announces 5 Tips for a Successful Stay in Pet-Friendly Accommodations 2Health News:Royal Flush Havanese Announces 5 Tips for a Successful Stay in Pet-Friendly Accommodations 3Health News:Royal Flush Havanese Announces 5 Tips for a Successful Stay in Pet-Friendly Accommodations 4Health News:ABC News Interviews Anne Buckley-Reen, Education Resources Inc. Faculty Member, on Yoga Therapy in the Classroom 2
... To Stay Happy and Healthy This WinterSAN JOSE, Calif., ... avoiding the "winter blues" is to set small goals, ... and exercising, for a well-rounded approach to life. This ... Day of the Year," January 26, 2009, designated by ...
... Strong Health and Economic Benefits of OTC Heartburn ... Consumer Healthcare Products Association (CHPA) and The Nielsen ... over-the-counter (OTC) heartburn medications and estimates that OTC ... each in office visits and medication costs annually. ...
... and print media; Mike Ditka, Frank Gifford, Michael Irvin, Tony Dorsett, ... Dickerson, Deacon Jones, Andre Reed, Tony Dorsett, Mercury Morris and many ... ... January 26, 2009 -- The Gridiron Greats Assistance Fund ...
... Inc. announces leading stem cell specialist Dr Nabil Dib, MD as ... President of the International Society for Cardiovascular Translational Research (ISCTR) and ... ... San Diego, CA (PRWEB) January 26, 2009 -- Stemedica Cell ...
... DNA solves another mystery when 57 year old Fred George discovered he ... fun and sometimes more seriously - accused his wife of having had ... rest of the family. , ... Pembroke, MA (PRWEB) January 26, 2009 ...
... injuries accounted for just 8 percent of all ... were relatively common in predominately male sports such ... (18 percent) and football (12 percent). Moreover, boys ... in soccer and baseball/softball. , ...
Cached Medicine News:Health News:Natural Solutions for the Most Depressing Day of the Year 2Health News:Natural Solutions for the Most Depressing Day of the Year 3Health News:Natural Solutions for the Most Depressing Day of the Year 4Health News:Natural Solutions for the Most Depressing Day of the Year 5Health News:CHPA, Nielsen: OTC Heartburn Therapy Saves Nearly $800 Million Annually, Vast Majority of OTC Heartburn Consumers Satisfied 2Health News:CHPA, Nielsen: OTC Heartburn Therapy Saves Nearly $800 Million Annually, Vast Majority of OTC Heartburn Consumers Satisfied 3Health News:100 NFL Legends Coming Together in Tampa During Super Bowl Week to Raise Awareness and Funds for Retired Players in Crisis 2Health News:100 NFL Legends Coming Together in Tampa During Super Bowl Week to Raise Awareness and Funds for Retired Players in Crisis 3Health News:100 NFL Legends Coming Together in Tampa During Super Bowl Week to Raise Awareness and Funds for Retired Players in Crisis 4Health News:Dr Nabil Dib Takes on Special Advisor Role to the Stemedica Board of Directors 2Health News:DNA Solves Switched at Birth Mystery ... After 57 Years 2Health News:DNA Solves Switched at Birth Mystery ... After 57 Years 3Health News:Shoulder injuries in US high school athletes occur more often in boys 2
... Centuries of German Craftsmanship ... instrumentation in the world. Ocutek® ... you! Only holders of the ... and eight-year apprenticeship, are qualified ...
... Endoscopic CycloPhotocoagulation (ECP) is a surgical ... endoscopy and visualized laser application. The ciliary ... by the surgeon, from the anterior or ... time. The target tissues are easily and ...
... a surgical approach to glaucoma management that ... The ciliary body (which produces aqueous humour) ... anterior or posterior segment, through the endoscope ... easily and accurately identified utilizing endoscopy. This ...
... (ECP) is a surgical approach to glaucoma ... laser application. The ciliary body (which produces ... from the anterior or posterior segment, through ... tissues are easily and accurately identified utilizing ...
Medicine Products: