FDA approves Nasacort nasal spray for kids
BRIDGEWATER, N.J. The Food and Drug Administration has approved Nasacort AQ Nasal Spray for children aged 2 to 5 for treating nasal symptoms of seasonal and perennial allergies, maker Sanofi-Aventis said.
The FDA based its approval on the results of a multi-center, randomized, double-blind and placebo-controlled study showing that the drug can be used safely and effectively to treat nasal symptoms of allergies in children aged 2 to 5.
“We welcome this new treatment option for our very young patients,” said Dr.
Steven Weinstein, lead investigator and director of the Allergy and Asthma Specialist Medical Group in Huntington Beach, Calif.
Independent pharmacy organization backs insurance coverage relief bill
ALEXANDRIA, Va. The National Community Pharmacists Association has joined with other groups representing smaller-scale employers to back new federal legislation that could ease the health insurance cost burdens on smaller businesses.
NCPA, the nation’s largest independent pharmacy organization, yesterday announced its endorsement of H.R. 6582, the Small Business Cooperative for Health Care Options to Improve Coverage for Employees [CHOICE] Act of 2008. The bill, introduced by U.S. House Small Business Committee chair Nydia Velazquez, D-N.Y., with support from both parties, is aimed at keeping smaller employers from falling prey to steadily rising health care and insurance costs.
To do so, the CHOICE bill creates private, voluntary purchasing cooperatives established under state insurance laws to provide excess claims insurance coverage to participating small businesses. The bill allows those employers to pool health risks over a larger number of insured plan participants, thus reducing costs and, ultimately, premiums.
H.R. 6582 also provides a refundable tax credit to small employers who purchase health insurance for their employees through the cooperative.
“With the cost of health insurance for small businesses rising 80 percent in the past eight years, the time for action has clearly arrived,” responded NCPA executive vice president and chief executive officer Bruce Roberts. The CHOICE bill, he added, “expands access to high-quality, affordable health insurance access for American small businesses and the self-employed. This bill provides the common-sense solutions to improve economic growth and productivity by promoting a healthier work force.”
Among other groups supporting the legislation: the American Optometric Association, American Rental Association, Coca-Cola Bottlers’ Association, Computing Technology Industry Association, International Franchise Association, National Association for Self-Employed, National Association of Home Builders, National Association of Realtors, National Black Chamber of Commerce, National Community Pharmacists Association, National Funeral Directors Association, National Gay & Lesbian Chamber of Commerce, National Restaurant Association, National Roofing Contractors Association, National Utility Contractors Association, U.S. Chamber of Commerce, U.S. Women’s Chamber of Commerce, and Women in Public Policy.
No connection between Lou Gehrig’s disease and statins, FDA says
WASHINGTON Cholesterol-lowering drugs do not increase the risk of Lou Gehrig’s disease, an analysis by the Food and Drug Administration has found.
The analysis, reported Monday in the journal Pharmacoepidemiology and Drug Safety, used data from 41 long-term controlled clinical trials involving statins. The FDA conducted the analysis after receiving an unusually large number of reports of Lou Gehrig’s disease in patients using the drugs in its Adverse Event Reporting System, but did not find an increase in the number of statin patients with the disease compared with those taking a placebo.
“The FDA’s review, which began in 2007, is an example of the agency working to analyze products [throughout their lifecycle] to keep healthcare professionals and patients informed of new and emerging safety data,” said Dr. Mark Avignan, director of the Division of Pharmacovigilance I at the FDA’s Center for Drug Evaluation and Research.
Lou Gehrig’s disease is the common name for amyotrophic lateral sclerosis, or ALS. It causes a gradual weakening of the muscles and impairment of speech ability.