FDA evaluating new indications for Ranexa
PALO ALTO, Calif. The Food and Drug Administration has notified CV Therapeutics that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa, according to Reuters. Ranexa is approved for the treatment of chronic angina in patients who already are using amlodipine, beta-blockers or nitrates.
This follows the FDA’s acceptance of two supplemental and one new drug application for Ranexa. The two supplemental applications state that Ranexa’s labeling should include a first line angina indication and a significant reduction in cautionary language. The new drug application calls for a labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes.
“We anticipate receiving approval for first line angina use, which would significantly expand the patient population eligible to receive Ranexa, and we are very pleased that the FDA also is now evaluating separate potential anti-arrhythmic and HbA1c reduction claims for Ranexa on the same timeline,” said Louis Lange, CV Therapeutics chairman and chief executive officer.
NACDS Foundation dinner raises $2.2 million
ALEXANDRIA, Va. The National Association of Chain Drug Stores this week held its Ninth Annual Foundation Dinner in New York City. This year’s fundraising event far surpassed previous records, increasing for the third consecutive year, raising $2.2 million for the NACDS Foundation.
The mission of the NACDS Foundation, the organization reported, is “to enhance support of pharmacy education, student scholarships, research and training that advance community pharmacy’s public service, and charitable organizations.”
Emmy award winner Tim Russert addressed the attendees, sharing his thoughts gained from a remarkable career, from being managing editor and moderator of Meet the Press as well as, political analyst for NBC Nightly News to serving as as senior vice president and Washington bureau chief of NBC News.
Donations raised from the dinner help advance the role of community pharmacy in numerous ways, including major research projects, pharmacy student scholarships, and charity work. Over the years, the NACDS Foundation has provided nearly $2 million in support to pharmacy education to help ensure the future of a strong and vibrant industry. And in the last year alone, it provided nearly $1 million in grants to charitable organizations that positively impact the lives of patients and the communities the chain drug industry serves.
“We could not be more thrilled or more grateful at the extensive generosity set forth by our benefactors,” said Phil Schneider, NACDS Foundation president. ”The contributions raised will enable the NACDS Foundation to continue, and even increase its work to advance community pharmacy.”
Kentucky pharmacists call on Sen. McConnell to fast-track Medicaid bill before holiday
FRANKFORT, Ky. Kentucky community pharmacy owners held a press conference today at Capital Pharmacy and Medical Equipment urging Senate Minority Leader Mitch McConnell, R-Ky., to help ensure S.1951, the Fair Medicaid Drug Payment Act of 2007, is brought to the Senate floor for a vote before it adjourns this year.
The bill is intended to fix the Medicaid generic prescription drug pharmacy reimbursement cuts called for by the Centers for Medicare & Medicaid Services that are scheduled to take effect early next year. Pharmacy advocates claim that the CMS cuts threaten the economic viability of community pharmacy, as well as patient access to pharmacy services.
“Community pharmacy owners like myself are being put in a terrible bind because of the coming cuts to Medicaid reimbursement,” said Mac Bray, owner of Capital Pharmacy and Medical Equipment. “My options will be to either turn my back on my Medicaid patients by limiting or dropping my services, or suffer huge financial losses by continuing to participate in the Medicaid program. Senate Minority Leader Mitch McConnell can spare myself and other pharmacists from making that Hobson’s Choice by pushing for the Senate to pass S. 1951 before they go home for the Holidays.”
“Who can stay in business at 36 percent below cost?” said Brad Hall, executive director of the Kentucky Pharmacists Association. “The federal government’s AMP [average manufacturers price] formula does not properly measure retail acquisition costs for community pharmacies like Capital Pharmacy and Medical Equipment here in Frankfort. The real world consequences of this disastrous federal policy will be felt most profoundly by patients, who will see their access to prescription drugs and the valued expertise of their trusted local pharmacists undermined. When that happens these patients will be forced to more expensive options such as visiting emergency rooms. This can all be avoided if Congress acts before the rule is fully implemented on Jan. 30, 2008.”