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TEVA » Topics » TEVA ANNOUNCES TENTATIVE APPROVAL OF GENERIC FLOMAX® CAPSULES

This excerpt taken from the TEVA 6-K filed Jan 31, 2008.

TEVA ANNOUNCES TENTATIVE APPROVAL OF GENERIC FLOMAX® CAPSULES

 

Jerusalem, 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.

 

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