GlaxoSmithKline disagrees with FDA decision regarding Advair

• GlaxoSmithKline PLC said Friday that it disagrees with proposed labeling changes by the Food and Drug Administration for the British drug maker's Serevent and Advair asthma treatments.
• The company said the FDA's proposed labeling changes would limit the asthma treatments for patients who had failed other treatment options first.
• GlaxoSmithKline noted that a July advisory panel to the agency had recommended no new changes to the labeling.
• The agency contends the products, which belong to a class of drugs known as long-acting beta 2-adrenergic agonists, should not be used as the first medicine to treat asthma because even though they may cut the number of asthma attacks, they may increase the chances of a more severe attack.
• Serevent was one of the five products cited by FDA whistleblower David Graham last year as posing potential dangers.
• The company counters that current labeling of the products are in line with current National Institutes of Health guidelines, and said that it will work with the agency to clear up differences of opinion regarding the drugs' benefit-to-risk profile.
• GlaxoSmithKline American depositary receipts shares fell $2.30, or 4.4 percent, to $49.75 in afternoon trading on the New York Stock Exchange.