Navigation Links
GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg
Date:7/3/2008

LIBERTY CORNER, N.J., July 3 /PRNewswire/ -- On June 27, 2008 GeneraMedix Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Epoprostenol for Injection 1.5 mg New Drug Application (NDA).

Epoprostenol for Injection 1.5 mg is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.

GeneraMedix Epoprostenol for Injection is available in 10 mL vials containing lyophilized epoprostenol sodium equivalent to 1.5 mg of epoprostenol. When reconstituted and diluted for administration with Water for Injection or Sodium Chloride Injection, the infusion solution is stable for up to 24 hours at room temperature. GeneraMedix's product differs from other currently available epoprostenol formulations, which require a special diluent and gel packs in a cold pouch in order to maintain stability for 24 hours.

Ronald F. Quadrel, President and CEO of GeneraMedix Inc. stated, "We are very excited with the FDA approval of our Epoprostenol for Injection. We feel that the advantages of our product may improve the ease of use, and more importantly, may help to improve the quality of life for patients with the most severe cases of pulmonary arterial hypertension. The addition of Epoprostenol for Injection to our cadre of FDA approved products fits well with our overall objective of providing injectable drugs that are difficult to source or manufacture while providing benefits for patients."

About GeneraMedix Inc.

GeneraMedix Inc. is a pharmaceutical company offering high quality injectable generic products to the hospital and specialty markets. In addition to its products already marketed, GeneraMedix has a significant number of injectable products under development, as well as a number of products currently under FDA review.
'/>"/>

SOURCE GeneraMedix Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
5. IsoTis Receives FDA Clearance for Accell Family of Products
6. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
7. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
8. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
9. XTL Receives Staff Letter From NASDAQ
10. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
11. Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 2014 , The first grants ... Paediatric Endocrinology (ESPE) Meeting  Investment supports innovative ... in the field of growth  , EMD ... Germany , today announced the first recipients of ... awards were announced during a Satellite Symposium organized by ...
(Date:9/18/2014)... About POCT POCT, ... clinical laboratory. It helps in making fast clinical ... medication. POCT is gaining popularity due to the ... as diabetes, heart disease, and obesity. It is ... to minimize errors during the diagnosis of patients. ...
(Date:9/18/2014)... , September 18, 2014 /PRNewswire/ ... Markets ( http://www.researchandmarkets.com/research/czvg3s/biocompatible ) has announced ... Materials - Global Strategic Business Report" ... (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ,This report analyzes the ... US$ Million by the following Product ...
(Date:9/18/2014)... , Sept. 18, 2014 ... of the "Global N-acetylcysteine Industry Report 2014" ... The Global N-acetylcysteine Industry Report 2014 is a ... of the global N-acetylcysteine industry. The ... including definitions, classifications, applications and industry chain structure. ...
Breaking Biology Technology:EMD Serono Awards Grant for Growth Innovation (GGI) for the First Time 2EMD Serono Awards Grant for Growth Innovation (GGI) for the First Time 3POCT Market in China 2014-2018 2Biocompatible Materials - Global Strategic Business Report 2014 2Biocompatible Materials - Global Strategic Business Report 2014 3Global N-acetylcysteine Industry Report 2014 2
... perfect example of the wonders of nanotechnology, in which common ... new and exciting possibilities. , Graphene ... graphitic carbon, which is used to make the pigment that ... to a one-atom-thick sheet. Graphene is among the strongest materials ...
... will result in over $80 million reduction in 2009 ... Pharmaceuticals,Inc. (Nasdaq: AMLN ) today announced a corporate ... 25 percent, or 340,employees, and reduce anticipated 2009 cash ... reduction are part of the,Company,s business plan to be ...
... Trubion Pharmaceuticals Inc.,(Nasdaq: TRBN ) announced today financial ... 30, 2008., Third Quarter and Nine Months Financial ... months ended Sept. 30, 2008, was,$3.8 million and $12.2 ... in 2007. Revenue in the third quarter and nine,months ...
Cached Biology Technology:Researchers discover method for mass production of nanomaterial graphene 2Researchers discover method for mass production of nanomaterial graphene 3Amylin Pharmaceuticals Announces Strategic Restructuring and Workforce Reduction 2Amylin Pharmaceuticals Announces Strategic Restructuring and Workforce Reduction 3Trubion Pharmaceuticals Inc. Reports Third Quarter and Nine Months 2008 Results 2Trubion Pharmaceuticals Inc. Reports Third Quarter and Nine Months 2008 Results 3Trubion Pharmaceuticals Inc. Reports Third Quarter and Nine Months 2008 Results 4Trubion Pharmaceuticals Inc. Reports Third Quarter and Nine Months 2008 Results 5Trubion Pharmaceuticals Inc. Reports Third Quarter and Nine Months 2008 Results 6
(Date:9/18/2014)... developed a unique method to use microbes buried in ... , The first microbe-powered, self-sustaining wastewater treatment system ... clean up waste from large farming operations and rural ... Haluk Beyenal and graduate student Timothy Ewing in the ... in the online edition of Journal of Power ...
(Date:9/18/2014)... can operate inside the bore of an MRI scanner ... research partnership program at Brigham and Women,s Hospital in ... in conjunction with real-time MRI images, can make prostate ... discomforting for the patient. The novel system also has ... precision. , Developed by a team of robotics engineers ...
(Date:9/18/2014)... acquire and creatively manipulate spoken language is unique to ... 6 million years of human evolution to make this ... candidate gene we now have," says Wolfgang Enard, Professor ... efforts to understand the molecular biological basis of language ... results of his latest study, undertaken in collaboration with ...
Breaking Biology News(10 mins):Researchers develop unique waste cleanup for rural areas 2Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 2Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 3Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 4Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 5Language evolution: Quicker on the uptake 2Language evolution: Quicker on the uptake 3
... UC Davis cancer researchers have found that older men ... regular CT scans over lymph node removal are at ... last week in the journal Cancer, indicate that physicians ... when discussing treatment options with their patients. ...
... University of Washington physicists are detecting radioactivity from ... a mammoth March 11 earthquake, but the levels are ... health. On March 16, the scientists began testing ... Building on the UW campus, looking for evidence of ...
... is available in German . , Innovations relating ... presented by KIT at the 2011 Hannover Messe from April ... KIT will present a hybrid Porsche racing car, developments in ... InnoEnergy for a European energy supply system, and the Energy ...
Cached Biology News:Frequent CT scanning for testicular cancer surveillance associated with secondary malignancies 2Frequent CT scanning for testicular cancer surveillance associated with secondary malignancies 3Physicists detect low-level radioactivity from Japan arriving in Seattle 2Physicists detect low-level radioactivity from Japan arriving in Seattle 3KIT presents innovations at the 2011 Hannover Messe 2KIT presents innovations at the 2011 Hannover Messe 3KIT presents innovations at the 2011 Hannover Messe 4KIT presents innovations at the 2011 Hannover Messe 5
Endomorphin-2. Cross reactivity: Endomorphin-1 3%, Met-enkephalin <0.03%, Leu-enkephalin <0.01% and beta-Endorphin <0.01%....
... Error-free cloning of BAC (100+kb), fosmid ... Greater insert stability than any othe BAC ... for high yields and easy recombinant DNA ... or transcription-free (pSMART VC) vectors for the ...
... System is used in conjunction ... PCR of problematic and/or GC-rich ... Solution with 10X PCRX Amplification ... broader magnesium concentration broader annealing ...
MAGP-2 (C-19)...
Biology Products: