GlaxoSmithKline has agreed with the US Food and Drug Administration on product labelling for its respiratory products Serevent Diskus and Advair Diskus. The agreement concludes ongoing discussions between GSK and FDA following an earlier advisory committee meeting about the safety of long-acting beta2-agonists, including salmeterol, the active ingredient in Serevent and one of the active ingredients in Advair.
According to the company release, the new product labels communicate the benefit risk profile of Serevent and Advair and help guide physicians in making appropriate prescribing decisions. Specifically, the new labels guide physicians to evaluate if a patient's asthma can be adequately controlled on other controller medications, such as inhaled corticosteroids (ICS), before adding a long-acting beta2-agonist (LABA), or whether a patient's disease severity clearly warrants initial treatment with an ICS and a LABA.
There have been over 48 million prescriptions dispensed for Serevent since introduction in 1995 and over 62 million prescriptions dispensed for Advair since introduction in 2001, stated a release.
Serevent Diskusis indicated for long-term, twice-daily administration in the maintenance treatment of asthma and in the prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.
Advair Diskusis indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 4 years of age and older.