FDA denies approval for Actavis hypertension treatment

By

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.

Tags
U.S., U.S. Food and Drug Administration
Join the Discussion
More News
Guy House

Kentucky Gunman Who Killed Two Inside Church Was Supposed to Attend Domestic Violence Hearing the Next Day

Trump eats Epstein files art

Trump Eats the Epstein Files in 'Genius' New L.A. Street Art: 'Needs to Be on Billboards Everywhere'

Loomer v Bondi on Epstein_07072025_1

MAGA Influencer Calls For 'Special Counsel' to Take Epstein Investigation Out of Trump AG's Hands

Daniel N. Pace

Alabama Man Who Set Girlfriend on Fire After Dousing Her With Vodka Learns His Fate