FDA declines to approve Bystolic as heart failure treatment
NEW YORK The Food and Drug Administration has declined to approve the use of a drug made by Forest Labs for heart failure, Forest announced Tuesday.
Forest said the agency did not approve its supplemental new drug application for Bystolic (nebivolol) tablets as a treatment for stable chronic heart failure. The drug already has approval as a treatment for hypertension.
Nevertheless, the FDA added information to the “Specific Populations” section of Bystolic’s product label about a placebo-controlled trial of 2,128 patients older than 70 years with chronic failure whose disease did not worsen while they took the drug, compared with those on placebo.
The company has said it will “continue to work closely” with the agency to discuss further steps.
FDA approves Menveo
CAMBRIDGE, Mass. Novartis has received Food and Drug Administration approval for a vaccine for meningococcal disease, the Swiss drug maker’s vaccines division announced Monday.
The FDA approved Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197) to prevent meningococcal disease caused by Neisseria meningitidis bacteria.
The disease infects more than 500,000 people each year, killing as many as 1-in-7 who contract it; it is often fatal within 48 hours. About one-in-five who survive have serious side effects, including limb amputations, learning disabilities, seizures and paralysis.
“The FDA approval of Menveo is an important milestone for adolescent immunization in the United States,” Novartis vaccines division head Andrin Oswald said in a statement. “According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease.”
Watson CEO to serve as GPhA chairman
NAPLES, Fla. Watson Pharmaceuticals president and CEO Paul Bisaro will serve as the Generic Pharmaceutical Association’s chairman for 2010-2011, GPhA announced.
Bisaro has led Watson since 2007, after a stint as president and CEO of Barr Labs that began in 1999. He has served on GPhA’s board of directors since 2008, most recently as vice chairman.
“Paul will provide us with a steady hand as GPhA next navigates the often turbulent issues of health reform and the nation’s economic recovery,” GPhA president and CEO Kathleen Jaeger said. “GPhA looks forward to working with him, our board of directors and executive committee in what will be a challenging year.”
The organization also elected Mylan Pharmaceutical president Tony Mauro as vice chairman, New Chemic senior consultant Rosendo Ferran as secretary-treasurer. Nycomed U.S. CEO Paul McGarty, Teva North America president and CEO William Marth, Sandoz president and CEO Christine Mundkur and Zydus Pharmaceuticals president and CEO Joe Renner will serve as at-large members on the board’s executive committee.