FDA appro for Teva's generic Proscar
Israel's Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted final approval for its Abbreviated New Drug Application to market a generic version of Merck & Co's Proscar (finasteride) tablets, 5mg, and adds that shipment of this product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded 180 days of marketing exclusivity.
Teva's finasteride tablets USP are indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate to improve symptoms and to reduce the risk of the need for prostate surgery.
Annual brand product sales in the USA were approximately $406.0 million for the 12 months ended March 2006, based on IMS data.
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