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Teva Announces Approval of Generic Accupril(R) Tablets |
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28 Aug 2007 |
Teva Pharmaceutical Industries Ltd. announced today that the FDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s hypertension treatment Accupril®
JERUSALEM, Israel | August 27, 2007 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that, following the expiration of pediatric exclusivity for U.S. Patent No. 4,743,450, the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s hypertension treatment Accupril® (Quinapril Hydrochloride) Tablets, 5 mg, 10 mg, 20 mg and 40 mg. Shipment of this product will commence shortly.
Total annual sales of Quinapril HCl Tablets in the U.S., including brand and generic sales, were approximately $150 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 Pharmaceutical Industries Ltd. |
