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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."
For product information please contact:
GeneraMedix Inc. Customer Service
1-866–GENERA–1
(1-866-436-3721)
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