Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Teva Pharmaceutical Industries has reported that the FDA has granted tentative approval for its abbreviated new drug application to market ropinirole HCl tablets, with base equivalents of 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg and 5mg.
Subscribe to our email newsletter
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.