RxTrials Institute Drug Pipeline Alert

Teva Pharmaceutical has received FDA approval for its ANDA to market epoprostenol, the first generic version of GlaxoSmithKline’s Flolan for injection.

Epoprostenol is indicated for the long-term IV treatment of primary pulmonary hypertension associated with the scleroderma spectrum of disease in New York Heart Association Class III and IV patients who do not respond adequately to conventional therapy, according to Teva.

The approval is for the 0.5-mg and 1.5-mg base/vial strengths as well as the sterile diluent. It comes roughly a week after the FDA granted tentative approval to Teva’s ANDA to market a generic version of Merck’s migraine treatment Maxalt (rizatriptan benzoate).

Maxalt was approved by the FDA in 1998 for the short-term treatment of migraine attacks in adults. Final approval of the generic is anticipated when the brand drug’s patent expires in June 2012.