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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 Tamsulosin Hydrochloride Capsules, 0.4 mg.
JERSUALEM, Israel | January 31, 2008 | 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 Tamsulosin Hydrochloride Capsules, 0.4 mg. Final approval of this product is expected upon expiry of patent protection for the brand product in October 2009.
Upon final approval, Teva's product will be the AB-rated generic equivalent of Boehringer Ingelheim's Flomax® Capsules, a product indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).
The brand product had annual sales of approximately $1.3 billion in the United States for the twelve months that ended September 30, 2007, based on IMS sales data.
About Teva
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. Over 80 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd. |
