FDA issues letter directing GSK to revise product labeling for Serevent and Advair

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.