You are here

Final Approval Granted to Generic Proscar

Jerusalem, Israel, June 19, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Proscar® (Finasteride) Tablets, 5 mg. 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 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.

Annual brand product sales in the U.S. were approximately $406 million for the twelve months ended March 2006, based on IMS data.

Source: Teva

Recent Headlines

First Devices Cleared for Diagnostic Testing Via Throat, Rectum Specimens
First New Medication for Seizure Clusters in More Than Two Decades
Novel, Low-cost Device Highly Accurate at Screening Newborn Jaundice
Mode Delivers Antivirals Safely, Cheaply to Remote Regions
Averts Disease Worsening, Reduces Potential for Blindness
Risk May Remain for 6 Months After Treatment
FDA Removes Boxed Warning With Drug’s Fifth Approval
Overeager Use of Recommendations Creates Problems
Artificial Intelligence Enables Platform to Detect Amyloid PET Status