GeneraMedix has received approval from the FDA for its Epoprostenol for Injection 1.5mg new drug application.
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GeneraMedix’s Epoprostenol for Injection 1.5mg 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.
Ronald Quadrel, president and CEO of GeneraMedix, said: “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.”
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