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