US FDA approves Teva's generic Uniretic

19 March 2007

Israeli drugmaker Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval for its Abbreviated New Drug Application for its fixed-dose tablets of moexipril HCl with hydrochlorothiazide, 7.5mg/12.5mg, 15mg/12.5mg and 15mg/25mg dosages.

Teva's new oral drug is the first AB-rated generic equivalent of Schwarz Pharma's Uniretic, a product indicated for the treatment of hypertension. The brand product has annual sales of approximately $30.0 million in the USA, based on IMS Health sales data.

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