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| Teva announces tentative approval of generic Requip® tablets
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. | |||
| 30 Nov 2007
, Jerusalem, Israel
: 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. About Teva Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe. |
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