Although we are disappointed in the receipt of a total response letter.

We will review the entire response and determine the appropriate next steps. .. Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension Actavis plc today confirmed that the Company has received a complete response letter from the U.S. Food and Medication Administration for its New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treating hypertension. Although we are disappointed in the receipt of a total response letter, Actavis continues to be focused on bringing treatments to advertise that address the significant public health issue of coronary disease, stated David Nicholson, Senior Vice President, Actavis Global Brands R&D. Bystolic is usually a effective and safe option that is commonly used in combination with additional antihypertensive medications to help patients reach blood pressure treatment goals.In the SPIRIT III Japan Registry, XIENCE V demonstrated a single-digit rate of main adverse cardiac occasions , and no cases of stent thrombosis out to 1 year. MACE is an important composite clinical measure of basic safety and efficacy outcomes for patients and is thought as cardiac death, heart attack , or ischemia-driven target lesion revascularization . In the SPIRIT III U.S. Trial, XIENCE V demonstrated an impressive low rate of extremely late stent thrombosis without additional events between two and 3 years, and a 43 % reduction in the chance of MACE when compared to TAXUS Express Paclitaxel-Eluting Coronary Stent Program at three years . In SPIRIT IV, among the largest randomized trials comparing two medication eluting stents, XIENCE V demonstrated a statistically significant 39 % reduction in target lesion failing in comparison to TAXUS at twelve months .