The FDA has approved indacaterol (in´´ da ka´ ter ol; Arcapta Neohaler – Novartis), an inhaled long-acting beta₂-agonist, for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Indacaterol is not approved for treatment of exacerbations of COPD or for treatment of asthma. It has been available in Europe as Onbrez Breezhaler since 2009.

The FDA has approved a fixed-dose, orally inhaled combination of the long-acting anticholinergic tiotropium and the long-acting beta2-adrenergic agonist olodaterol (Stiolto Respimat — Boehringer Ingelheim) for long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Tiotropium (Spiriva Handihaler, Spiriva Respimat) and olodaterol (Striverdi Respimat) are also available separately for once-daily treatment of...

The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

The FDA has approved an inhalation solution formulation of the long-acting antimuscarinic agent (LAMA) glycopyrrolate (Lonhala Magnair – Sunovion) for maintenance treatment of chronic obstructive pulmonary disease (COPD). The new formulation is delivered using a portable, handheld, electronic nebulizer. Glycopyrrolate is also available as a dry powder inhaler, both alone (Seebri Neohaler) and in combination with indacaterol (Utibron Neohaler), and as a metered-dose inhaler in combination with formoterol (Bevespi Aerosphere). Lonhala Magnair is the first nebulized LAMA to become...

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

The FDA has approved two new inhalers for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Seebri Neohaler (Novartis) contains the long-acting anticholinergic glycopyrrolate. Utibron Neohaler (Novartis) contains both glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) indacaterol. Glycopyrrolate/indacaterol is the third fixed-dose combination of a long-acting anticholinergic and a LABA to become available in the US; umeclidinium/vilanterol (Anoro Ellipta) and tiotropium/olodaterol (Stiolto Respimat) were approved...

Tiotropium bromide, an inhaled long-acting anticholinergic available since 2004 as a dry powder inhaler (Spiriva Handihaler) for once-daily treatment of chronic obstructive pulmonary disease (COPD), has now also been approved in an inhalation spray formulation (Spiriva Respimat – Boehringer Ingelheim). According to the manufacturer, the Respimat device improves delivery of tiotropium to the lungs because, unlike with the Handihaler, it is not dependent on the strength of the patient’s breath intake.

The FDA has approved Trelegy Ellipta (GSK), a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, the long-acting antimuscarinic agent (LAMA) umeclidinium, and the long-acting beta₂-agonist (LABA) vilanterol. It is available as a dry powder inhaler for once-daily maintenance treatment of COPD and to reduce COPD exacerbations in patients with a history of exacerbations. Trelegy Ellipta is the first three-drug inhaler for treatment of COPD to become available in the US.

The FDA has approved Duaklir Pressair (Circassia), a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the longacting beta₂-adrenergic agonist (LABA) formoterol fumarate, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Aclidinium/formoterol is the fifth LAMA/LABA combination to be approved in the US for this indication.

The FDA has approved an inhaled fixed-dose combination (Breo Ellipta – GSK/Theravance) of the corticosteroid fluticasone furoate and the long-acting beta₂-adrenergic agonist (LABA) vilanterol trifenatate for once-daily treatment of chronic obstructive pulmonary disease (COPD).