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.
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. Paragraph IV certification implies that the ANDA applicant may certify that a listed patent is invalid or will not be infringed on by the manufacture, use or sale of the generic product.