GSK announces new product labels for Serevent® and Advair®

RESEARCH TRIANGLE PARK, N.C. – GlaxoSmithKline today announced that it has agreed with the U.S. Food and Drug Administration on product labeling 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.

GSK is pleased to have reached an agreement with FDA on product labeling that is in the best interest of patients. 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.

The addition of a medication guide will also ensure patients have easy-to-understand information on the safety and proper use of these two important medicines.

GSK has confidence in the proven safety profile of Serevent and Advair when these products are used appropriately. These medicines have been extensively studied in patients with asthma. 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.

About Serevent:

Serevent Diskusis indicated for long‑term, twice‑daily (morning and evening) 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.

Long‑acting beta2‑adrenergic agonists, such as salmeterol, the active ingredient in Serevent Diskus,may increase the risk of asthma‑related death. Therefore, when treating patients with asthma, Serevent Diskus should only be used as additional therapy for patients not adequately controlled on other asthma‑controller medications (e.g. low- to medium‑dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including Serevent Diskus. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short‑acting beta2‑agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled, short‑acting beta2‑agonists.

About Advair:

Advair Diskusis indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 4 years of age and older.

Long‑acting beta2‑adrenergic agonists, such as salmeterol, one of the active ingredients in Advair Diskus, may increase the risk of asthma‑related death. Therefore, when treating patients with asthma, physicians should only prescribe Advair Diskusfor patients not adequately controlled on other asthma‑controller medications (e.g., low- to medium‑dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo‑controlled US study that compared the safety of salmeterol (Serevent® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma‑related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo).

Advair Diskusis not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short‑acting beta2‑agonists.

Advair Diskusis NOT indicated for the relief of acute bronchospasm.

Please consult full prescribing information for Advair and Serevent.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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