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:6/23/2016)... June 22, 2016  Amgen (NASDAQ: AMGN ... QB3@953 life sciences incubator to accelerate the ... shared laboratory space at QB3@953 was created to help ... obstacle for many early stage organizations - access to ... sponsorship, Amgen launched two "Amgen Golden Ticket" awards, providing ...
(Date:6/22/2016)... , June 22, 2016 Research and ... Global Markets" report to their offering. ... billion in 2014 from $29.3 billion in 2013. The market is ... of 13.8% from 2015 to 2020, increasing from $50.6 billion in ... projected product forecasts during the forecast period (2015 to 2020) are ...
(Date:6/22/2016)... ... June 22, 2016 , ... Quantitative Radiology Solutions, ... and current participant in the Phase 1 Ventures program, is leveraging regional and ... Quantitative Radiology Solutions helps physicians make better treatment decisions by quantifying medical imaging ...
(Date:6/22/2016)... ... 22, 2016 , ... The Immigrant Journey Awards , ... to North Texas and the nation, recently held its annual luncheon program. ... civic and economic vitality of North Texas. Proceeds from the event are used ...
Breaking Biology Technology:
(Date:5/16/2016)...   EyeLock LLC , a market leader of ... an IoT Center of Excellence in Austin, ... of embedded iris biometric applications. EyeLock,s iris ... security with unmatched biometric accuracy, making it the most ... EyeLock,s platform uses video technology to deliver a fast ...
(Date:5/3/2016)... , May 3, 2016  Neurotechnology, a provider ... MegaMatcher Automated Biometric Identification System (ABIS) , ... multi-biometric projects. MegaMatcher ABIS can process multiple complex ... any combination of fingerprint, face or iris biometrics. ... SDK and MegaMatcher Accelerator , which ...
(Date:4/26/2016)... and LONDON , April ... part of EdgeVerve Systems, a product subsidiary of ... today announced a partnership to integrate the Onegini ...      (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ) ... their customers enhanced security to access and transact ...
Breaking Biology News(10 mins):