Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA)announced that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDAfor Moexipril HCland HydrochlorothiazideTablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg and 15 mg/25 mg. Shipment of these products will begin immediately.
Teva’s Moexipril HCl and Hydrochlorothiazide Tablets are the first AB-rated generic equivalent of Schwarz Pharma’s Uniretic? Tablets, a product indicated for the treatment of hypertension.
The brand product had annual sales of approximately $30 million in the U.S., based on IMS sales data.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company.
The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.