Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration has granted approval for the company’s abbreviated new drug application to market a generic version of a pulmonary hypertension drug.
Petah Tikva-based Teva received approval for its epoprostenol, the first generic version of GlaxoSmithKline’s Flolan 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 US for the twelve months that ended February, 2008, based on IMS sales data.
Flolan is used as an intravenous treatment for 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. The drug is administered continuously, as its effects wear off after a few minutes. It is often delivered via a portable pump.
“The cost of specialty pharmaceuticals today can be a barrier for patients with pulmonary hypertension. Teva’s introduction of epoprostenol is important in reducing the overall financial burden of treating this life threatening disease,” stated a leading authority on pulmonary hypertension, Dr. Richard Channick, Professor of Medicine at the University of California, San Diego Medical Center.
Shares in Teva were unchanged yesterday on Nasdaq trading, closing at $45.83, to reflect a market cap of $35.2 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on April 29, 2008
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