Teva Pharma Gets Tentative Approval From FDA For Generic Flomax Capsules

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA | news | PowerRating | PR Charts ) said it received tentative approval from United States Food and Drug Administration, or FDA, for the company's Abbreviated New Drug Application, or ANDA, for Tamsulosin Hydrochloride Capsules, 0.4 mg.

The company anticipates the final approval of this product upon expiry of patent protection for the brand product in October 2009.

After the final approval, Teva's product would be the AB-rated generic equivalent of Boehringer Ingelheim's Flomax Capsules, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

According to the IMS data, the brand product had annual sales of about $1.30 billion in the United States for the twelve months that ended September 30, 2007.

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