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|November 30, 2007 2:14 p.m.|
|Teva Announces Tentative Approval Of Generic Requip® Tablets|
Jerusalem, Israel, November 30, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's Requip® (Ropinirole HCl) Tablets, Eq. 0.25 mg base, 0.5 mg base, 1 mg base, 2 mg base, 3 mg base, 4 mg base and 5 mg base. Final approval of Teva's Ropinirole HCl Tablets is expected upon expiry of patent protection for the brand product on May 19, 2008. Upon final approval, Teva's product will be the AB-rated generic equivalent of 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. The brand product had annual sales of approximately $455 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.