The FDA has granted marketing approval for Teva Pharmaceutical Industries' generic version of Schwarz Pharma's hypertension drug Uniretic.
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Teva said that the agency had approved its abbreviated new drug application for moexipril HCl and hydrochlorothiazide tablets, in 7.5mg/12.5mg, 15mg/12.5 mg and 15mg/25mg strengths. The company said that shipment of these products will begin immediately.
Israel-based Teva said that Uniretic has annual sales of approximately $30 million in the US, based on IMS sales data.