TEVA GETS FIRST APPROVAL FOR GENERIC PROSCAR TABLETS

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The FDA has granted final approval to Teva harmaceutical's abbreviated new drug application (ANDA) to market its generic version of Merck's Proscar (finasteride) tablets in dosages of 5 mg. Shipment of this product will begin immediately, the company said.

Finasteride is indicated for treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms and to reduce the risk of the need for prostate surgery.