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Teva Announces Tentative Approval Of Sildenafil Citrate Tablets, 20 Mg |
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11 Aug 2007 |
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, 20 mg.
JERUSALEM, Israel | August 10, 2007 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, 20 mg. Final approval of this product is anticipated upon expiration of patent protection for the brand product in March 2012.
Upon final approval, Teva's Sildenafil Citrate Tablets will be the AB-rated generic equivalent of Pfizer's Revatio® Tablets, a product indicated for treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability.
The brand product had annual sales in the U.S. of approximately $93 million for the twelve months ended June 30, 2007, based on IMS sales data.
Teva Pharmaceutical Industries Ltd., 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 human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 75 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceuticals |
