Teva Announces Tentative Approval Of Generic Flomax(R) Capsules

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry;  Prostate / Prostate Cancer
Article Date: 04 Feb 2008 - 11:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced 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.

Teva Pharmaceutical Industries Ltd.