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. Headquartered in Liberty Corner, New Jersey, the company was founded in July 2004. Additional information is available at the company's website at http://www.generamedix.com.


'/>"/>
SOURCE GeneraMedix Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:2/11/2016)... , ... February 11, 2016 , ... ... medicine, has announced a new agreement with Bankok,Thailand-based Global Stem Cells Network (GSCN) ... phsyicians in 15 Latin American countries, including Mexico, Costa Rica, Dominican Republic, Colombia, ...
(Date:2/10/2016)... -- The Maryland House of Delegates and House Speaker ... Maryland School of Medicine Dean E. Albert Reece ... System President and CEO Robert Chrencik , MBA, ... given to the public by the leader of the ... and Mr. Chrencik for their contributions to our statewide ...
(Date:2/10/2016)... RICHLAND, Wash., Feb. 10, 2016  IsoRay, Inc. (NYSE ... seed brachytherapy and medical radioisotope applications for the treatment ... cancers, today announced its financial results for the second ... December 31, 2015. --> ... second quarter of fiscal 2016, which ended December 31, ...
(Date:2/10/2016)... ... February 10, 2016 , ... HOLLOWAY AMERICA, a leading ... (ISPE) Rocky Mountain Chapter 21st Annual Vendor Exhibition on Thursday, February 18, 2016. ... tables for its annual event, which will run from 3:00 p.m. - 8:30 ...
Breaking Biology Technology:
(Date:1/25/2016)... Pa. , Jan. 25, 2016   Unisys Corporation ... system at John F. Kennedy (JFK) International Airport, New ... Protection (CBP) identify imposters attempting to enter the ... not belong to them. pilot testing of the ... initially at three terminals at JFK during January 2016. --> ...
(Date:1/22/2016)... DUBLIN , Jan. 22, 2016 /PRNewswire/ ... announced the addition of the "Global ... report to their offering. --> ... of the "Global Biometrics Market in ... offering. --> Research and ...
(Date:1/20/2016)... 20, 2016   MedNet Solutions , an innovative ... of clinical research, is pleased to announce the attainment ... are the result of the company,s laser focus on ... , it,s comprehensive, easy-to-use and highly affordable cloud-based ... Key MedNet growth achievements in 2015 include: ...
Breaking Biology News(10 mins):