FDA clears Teva's Flolan ANDA

Israel-headquartered Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application to market its epoprostenol, the first generic version of UK drug giant GlaxoSmithKline's Flolan for Injection. Teva's approval is for the 0.5mg base/vial and 1.5mg base/vial strengths as well as the sterile diluent. The brand product had annual sales of $80.0 million in the USA for the 12 months that ended February, based on IMS Health 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.

"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, Richard Channick, professor of medicine at the University of California, San Diego Medical Center, in a Teva press release.