FDA grants approval to generic finasteride

Teva Pharmaceutical Industries Ltd. has received final FDA approval to market a generic formulation of finasteride tablets, 5 mg. Finasteride is indicated for treatment of symptomatic BPH. Shipments will begin immediately.

As the first company to file the application with a paragraph IV certification for this product, Teva said it has been awarded marketing exclusivity for its formulation through mid-December 2006.