Upon final approval, Teva’s product will be the AB-rated generic equivalent of GlaxoSmithKline’s Requip tablets, and will be indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease as well as treatment of moderate to severe primary restless leg syndrome.
Final approval of Teva’s ropinirole HCl tablets is expected upon expiry of patent protection for the brand product on May 19, 2008.