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:6/27/2016)... , June 27, 2016   Ginkgo Bioworks , ... industrial engineering, was today awarded as one of ... of the world,s most innovative companies. Ginkgo Bioworks ... for the real world in the nutrition, health ... work directly with customers including Fortune 500 companies ...
(Date:6/24/2016)... SAN DIEGO , June 24, 2016 /PRNewswire/ ... that more sensitively detects cancers susceptible to PARP ... individual circulating tumor cells (CTCs). The new test ... of HRD-targeted therapeutics in multiple cancer types. ... therapies targeting DNA damage response pathways, including PARP, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita Politecnica ... in people with peritoneal or pleural mesothelioma. Their findings are the subject of a ... , Diagnostic biomarkers are signposts in the blood, lung fluid or tissue of ...
(Date:6/23/2016)... ... June 23, 2016 , ... UAS LifeSciences, one of the ... brand, UP4™ Probiotics, into Target stores nationwide. The company, which has been manufacturing ... to its list of well-respected retailers. This list includes such fine stores as ...
Breaking Biology Technology:
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
(Date:4/14/2016)... BioCatch ™, the global ... the appointment of Eyal Goldwerger as CEO. ... Goldwerger,s leadership appointment comes at a time of significant ... of its platform at several of the world,s largest ... unique cognitive and physiological factors, is a winner of ...
(Date:3/31/2016)... RATON, Florida , March 31, 2016 ... LEGX ) ("LegacyXChange" or the "Company") ... for potential users of its soon to be launched ... video ( https://www.youtube.com/channel/UCyTLBzmZogV1y2D6bDkBX5g ) will also provide ... the use of DNA technology to an industry that ...
Breaking Biology News(10 mins):