Teva Obtains Approval for Generic Flolan for Injection

Teva Pharmaceutical Industries has announced that the FDA has granted approval for the company’s abbreviated new drug application to market its epoprostenol, the generic version of 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.

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.