The US health regulator Food and Drug Administration (FDA) has denied approval to generic drug maker Actavis Plc for its hypertension treatment comprising a fixed-dose combination of valsartan and nebivolol.
Responding over the FDA’s decision, the company in a released statement said that it would first review the complete response letter of the regulating authority and then take decision on its further steps.
FDA always issues a response letter, highlighting the plus and minus of the drugs, in case a new or generic treatment is not approved in its current form.
David Nicholson, Senior Vice President, Actavis Global Brands R&D, said, “Although we are disappointed in the receipt of a complete response letter, Actavis remains committed to bringing treatments to market that address the significant public health issue of cardiovascular disease.”
“Bystolic is a safe and effective option that is commonly used in combination with other antihypertensive medications to help patients reach blood pressure treatment goals. We will review the complete response and determine the appropriate next steps,” he said.
Actavis, however, declined to furnish any further details of the letter.
But the company maintained that during the clinical trial, its drug combination was found effective in lowering blood pressure in hypertension patients more than the independent doses of valsartan and nebivolol.
Meanwhile, the company’s shares closed at USD 254.20 at the New York Stock Exchange on Thursday.
The health experts at CDC call hypertension a “silent killer”. According to them, the health problem often comes with no symptoms or warning signs and has been linked with serious cardiovascular (CV) disease like stroke and myocardial infarction.