RESEARCH TRIANGLE PARK, N.C., June 2 GlaxoSmithKline (NYSE: GSK) today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent« and Advair«. The letter concludes discussions between GSK and the agency following FDA advisory committee meetings regarding the safety profile of long-acting beta2-agonists in the treatment of asthma, including salmeterol, the active ingredient in Serevent and one of the active ingredients in Advair. The changes communicated by the FDA reflect class labeling for all LABA containing products and are specific to product labels in the U.S.
GSK will work quickly to implement changes described in the FDA's correspondence and communicate these changes to healthcare providers.
Advair and Serevent remain important treatment options for appropriate patients with asthma and COPD.
For full FDA announcement click here. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm
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Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.