(Reuters) – 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.
(This story corrects paragraph 6 to say Wednesday, not Thursday)
(Reporting by Ankit Ajmera in Bengaluru; Editing by Kirti Pandey)