FDA denies approval for Actavis hypertension treatment

Generic drug maker Actavis Plc said the U.S. health regulator denied an approval for its hypertension treatment, a fixed-dose combination of nebivolol and valsartan.

The company said it would review the U.S. Food and Drug Administration's complete response letter and decide on appropriate next steps.

The regulator issues a complete response letter when a new or generic treatment cannot be approved in its current form.

Actavis did not give any further details on the contents of the letter.

In a study, the drug combination was found more effective in reducing blood pressure in patients of hypertension, compared with independent doses of nebivolol and valsartan, Actavis said.

The company's shares closed at $254.20 on the New York Stock Exchange on Wednesday. 

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Actavis, U.S., nebivolol, valsartan, U.S. Food and Drug Administration

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