US FDA grants tentative approval to Teva's generic Flomax capsules
01 Feb 2008
The US Food and Drug Administration has granted tentative approval for Teva Pharmaceutical's abbreviated new drug application (ANDA) for tamsulosin hydrochloride capsules in 0.4mg dosage.
Teva expects to receive final approval for the product upon expiry of patent protection for Boehringer Ingelheim's flomax capsules in October 2009.
Upon final approval, Teva's product will be the AB-rated generic equivalent of Boehringer's flomax capsules, 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.
Teva Pharmaceutical Industries Ltd, headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. Over 80 per cent of Teva's sales are in North America and Europe.