Teva Pharmaceutical Industries Ltd announced that the US Food and Drug Administration has granted tentative approval for the Company's ANDA for Finasteride Tablets USP, 5 mg. Final approval is subject to the expiration of patent protection on June 19, 2006 and any exclusivity period.
Teva's Finasteride Tablets USP, 5 mg are the AB-rated generic equivalent of Merck's Proscar Tablets, a product indicated for improvement of symptoms of benign prostatic hyperplasia, and reduction of risks of acute urinary retention and need for prostate surgery in patients with BPH.
Meantime, US FDA has granted final approval for Teva's Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL pre-filled syringe. A launch date has not yet been finalized.
Medroxyprogesterone Acetate Injectable Suspension is the generic equivalent of Pfizer's Depo-Provera, an injectable contraceptive.
Annual sales of the brand product sold in syringes are approximately $109 million.
This is the second presentation of this product for which Teva has obtained a generic drug approval. In July, the FDA granted final approval for Teva's ANDA for Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL in single-dose vials. Shipment of this product commenced in September.