GlaxoSmithKline (GSK) has received a letter from the FDA directing revisions to product labeling for its respiratory products Serevent and Advair.
Advair contains fluticasone and salmeterol. Fluticasone is a steroid. Advair prevents the release of substances in the body that cause inflammation. Salmeterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.
Advair is used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.
GSK said that combination asthma medicines, such as Advair, that contain a LABA and an inhaled corticosteroid (ICS) play an important role in the treatment of asthma because they treat both main causes of asthma symptoms – inflammation and bronchoconstriction.
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 US.
GSK will work quickly to implement changes described in the FDA’s correspondence and communicate these changes to healthcare providers.