Teva Pharmaceutical (TEVA) Receives FDA Approval for Generic Flolan
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its epoprostenol, the first generic version of GlaxoSmithKline's Flolan (NYSE: GSK) for Injection. Teva's approval is for the 0.5 mg base/vial and 1.5 mg base/vial strengths as well as the sterile diluent. The brand product had annual sales of approximately $80 million in the United States for the twelve months that ended February, 2008, based on IMS sales data.
This product 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.[SM]
This product 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.[SM]
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