Navigation Links
FDA Extends Marketing Exclusivity for INOMAX®
Date:1/5/2011

CLINTON, N.J., Jan. 5, 2011 /PRNewswire/ -- Ikaria, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted INOMAX® (nitric oxide) for inhalation an additional six months of marketing exclusivity, known as "pediatric exclusivity."  The action extends exclusivity for INOMAX from January 2013 to July 2013. This decision was based on data submitted from three clinical trials of INOMAX in pre-term infants at risk for bronchopulmonary dysplasia (BPD), a serious respiratory condition resulting from lung injury.

Data from three large, multi-center, double-blind, placebo-controlled clinical trials examining the efficacy and safety of INOMAX in pre-term infants less than or equal to 34 weeks gestational age were submitted to the FDA.  Although the safety and tolerability of INOMAX has been shown in these trials, substantial evidence of efficacy has not been demonstrated. Therefore, Ikaria continues to study the efficacy of INOMAX for the prevention in BPD in pre-term infants through its Phase III clinical trial, which commenced in December 2009. INOMAX is not indicated for the prevention of BPD in pre-term infants.

INOMAX is indicated for the treatment of hypoxic respiratory failure, or HRF, in term and near-term (greater than 34 weeks) infants.  HRF occurs when the cells in the body are unable to receive enough oxygen, and is a life-threatening condition for newborns. INOMAX helps critically ill newborns breathe more effectively by dilating the blood vessels of the lungs, which improves oxygen uptake and maximizes oxygen supply to the tissues of the body. Use of INOMAX reduces the need for extracorporeal membrane oxygenation (ECMO), a highly-invasive and expensive surgical procedure in which an infant's blood is mechanically oxygenated by connecting the newborn to a heart-lung machine.

INOMAX is delivered as part of a comprehensive offering known as INOtherapy®.  In addition to INOMAX, INOtherap
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)
2. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
3. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
4. FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
5. Protalix BioTherapeutics Extends Research Agreement With Yissum Based on Promising Acetylcholinesterase Program Results in Animal Study
6. Everolimus (RAD001) Significantly Extends Progression-Free Survival in Advanced Kidney Cancer Patients After Failure of Other Targeted Therapy
7. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
8. Neurosciences Institute Discovers Drug Extends Stroke Treatment Time to 24 Hours, Repairs Brain Tissue
9. Lincare Holdings Inc. Extends Terms of Employment Agreements with Executive Officers
10. Applied Seals North America Extends Global Network With Addition of Distributor in Europe
11. Circassia Extends its Clinical-Stage Portfolio With Phase II Trials of T-Cell Vaccines Against House Dust Mite and Cat Allergies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... , Spanien, September 23, 2014 ... dass sich Fernzugriffe auf eTMF im Jahr ... ermöglicht den Sponsoren von klinischen Versuchsreihen, die ... und Vollständigkeit von Stammdateien mit Informationen über ... zu erfüllen     Die bisher ...
(Date:9/22/2014)... 22, 2014 Levi & Korsinsky is investigating ... "the Company") (NasdaqGS: SIAL ) for possible ... law in connection with the sale of the Company ... to learn more about the investigation: http://zlkdocs.com/SIAL-Info-Request-Form_ma-2199 , ... to you. Under the terms of the ...
(Date:9/22/2014)... , Sept. 22, 2014 Avanir Pharmaceuticals, ... it is offering to sell $200 million of its ... Deutsche Bank Securities and BofA Merrill Lynch are acting ... grant the underwriters a 30-day option to purchase additional ... to be sold in the offering are being sold ...
Breaking Medicine Technology:Branchenweite Umfrage zeigt, dass sich Fernzugriffe auf eTMF im Jahr 2015 verdoppeln werden 2Branchenweite Umfrage zeigt, dass sich Fernzugriffe auf eTMF im Jahr 2015 verdoppeln werden 3Branchenweite Umfrage zeigt, dass sich Fernzugriffe auf eTMF im Jahr 2015 verdoppeln werden 4Branchenweite Umfrage zeigt, dass sich Fernzugriffe auf eTMF im Jahr 2015 verdoppeln werden 5SIGMA-ALDRICH INVESTOR ALERT: Levi & Korsinsky, LLP Investigates the Board of Directors of Sigma-Aldrich Corporation In Connection with the Sale of the Company to Merck -- SIAL 2Avanir Pharmaceuticals Announces Proposed Public Offering of Common Stock 2Avanir Pharmaceuticals Announces Proposed Public Offering of Common Stock 3
... S.C., Sept. 9 At approximately 3:21,PM ... Chairman and Founder of,CureHIV.us, agreed to act ... Global,Humanceuticals, Inc,s., new extremely effective, safe and ... non-government, U.S.,and foreign institutions, organizations, and corporations, ...
... Effective Antibiotics Against ,Superbugs, BOSTON, Sept. 6 ... may have discovered the path,toward developing better drugs ... resistance to common antibiotics. The,researchers have discovered a ... opens to door to new avenues of research., ...
Cached Medicine Technology:Dr. Roger Kenneth Hershline PhD MD, CEO of Global Humanceuticals, Inc. Donates New HIV Drug 2Boston University Biomedical Engineers Find Chink in Bacteria's Armor 2Boston University Biomedical Engineers Find Chink in Bacteria's Armor 3
(Date:9/23/2014)... September 23, 2014 Névo takes a ... precision timepiece and adding advanced activity tracking and phone ... monitors steps, distance, calories burned, and more. , ... to adopt healthy habits in their busy lives to ... small changes that produce healthy results, but until now, ...
(Date:9/23/2014)... Parsippany, NJ (PRWEB) September 23, 2014 Many ... hypnosis . Everyone has seen nightclub or television acts in ... of audience members and then uses the power of suggestion ... Most people have also heard about hypnosis as an aid ... examples represent only a fraction of the ways hypnotism can ...
(Date:9/23/2014)... 2014 Medicine in Motion (MIM) is proud ... at 711 W. 38th, Suite G4. After serving the area’s ... location, increased demand for MIM’s superior care led to the ... are extremely excited about bringing our high-quality brand of sports ... Medicine in Motion. “We’ll continue to provide patients with the ...
(Date:9/23/2014)... BuyTopDress.com, a popular supplier of wedding dresses and special occasion ... marine ball dresses . Along with this, the firm ... new items; all of them are now provided with deep ... BuyTopDress.com has won more than 2000 happy customers in the ... products and after-sale services. The company is offering thousands of ...
(Date:9/22/2014)... Plainfield, IL (PRWEB) September 23, 2014 ... in need of a new design and restructuring for their ... the organization had grown. They needed a way to navigate ... accessible way, as well as present the look and feel ... style. , In 1971, when Patch Adams graduated from ...
Breaking Medicine News(10 mins):Health News:Nevo changes the face of fitness wearables with an analogue watch combining activity tracking, phone notifications, and LED goal progress indicators for active lifestyles 2Health News:Nevo changes the face of fitness wearables with an analogue watch combining activity tracking, phone notifications, and LED goal progress indicators for active lifestyles 3Health News:Hypnosis: What You Don't Know, Dr. Richard Dauber with Morris Psychological Group Dispels Myths and Offers Tips about a Valuable Therapeutic Approach 2Health News:Hypnosis: What You Don't Know, Dr. Richard Dauber with Morris Psychological Group Dispels Myths and Offers Tips about a Valuable Therapeutic Approach 3Health News:Hypnosis: What You Don't Know, Dr. Richard Dauber with Morris Psychological Group Dispels Myths and Offers Tips about a Valuable Therapeutic Approach 4Health News:Austin Sports Medicine Practice to Host Grand Opening Event for Second Location 2Health News:Fashionable Marine Ball Dresses Added To BuyTopDress.com’s Collection 2Health News:Idea Marketing Group Launches a New Website for The Gesundheit! Institute 2Health News:Idea Marketing Group Launches a New Website for The Gesundheit! Institute 3
... of studies,School-based sexual abuse prevention programs can teach children ... ,However, the programs have a downside: they ... the review cautions. ,,It was a concern that ... review, but we were pleased that there was an ...
... every time you feel a cold starting isnt such a good ... will most probably end up getting the sniffles . ... over several decades and including more than 11,000 people who took ... ,The review, according to the researchers at the Australian National ...
... of pregnancy rumours once again when she was pictured with ... York premiere of John Travolta starrer Hairspray dressed in a ... reports the Daily Mail. ,Holmes sparked off rumours ... child when she was spotted with bump while visiting new ...
... Sreemathi Wednesday said the government was not averse to inviting ... of a mosquito borne fever in the state that has ... different expert teams have arrived in the state since the ... reports, which have confirmed the fever as chikunguniya and nothing ...
... reserved seats for students suffering from AIDS and cancer in ... reserved one seat for each of the fifty-six courses that ... cancer. ,However, the university feels that one seat ... being, since it do not expects many patients queuing up ...
... that set out to assess the effectiveness and tolerability ... methods of contraception found that they were all good ... implant was found to be any more or less ... ,,The most common side effect with all the implants ...
Cached Medicine News:Health News:School-based Sexual Abuse Prevention Programs 2Health News:School-based Sexual Abuse Prevention Programs 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: