Table 1. Approved LABA/LAMA FDCs.
| LABA/LAMA | Approval |
|---|---|
| IND/GLY 110/50 μg q.d. | Delivered via a dry powder inhaler device (Breezhaler) |
| The drug dose has been approved in over 90 countries (other than the United States) including the EU and Asian countries | |
| In the United States, the FDC is approved as indacaterol/glycopyrrolate 27.5/15.6 μg b.i.d. | |
| VI/UMEC 25/62.5 μg q.d. | Delivered via a dry powder inhaler device (Ellipta) |
| Approved in the EU, the United States, Asia and other countries for maintenance treatment of COPD | |
| OLO/TIO 2.5/2.5 μg two inhalations q.d. | Delivered via a soft-mist inhaler device (Respimat) |
| Approved in the EU, the United States, and some Asian countries, e.g., Korea, for treatment of COPD | |
| FOR/ACLI 400/12 μg b.i.d. | Delivered via a dry powder inhaler device (Genuair) |
| Approved in the EU for maintenance treatment of COPD | |
| FF/GP 4.8/9 μg two inhalations b.i.d.* | Delivered via a metered-dose inhaler device (Aerosphere) |
| Approved in the United States for maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema |
*Not approved in Korea.
LABA/LAMA: long-acting β2-agonist/long-acting muscarinic antagonist; FDC: fixed-dose combination; IND/GLY: indacaterol/glycopyrronium; q.d.: once daily; VI/UMEC: vilanterol/umeclidinium; COPD: chronic obstructive pulmonary disease; OLO/TIO: olodaterol/tiotropium; FOR/ACLI: formoterol/aclidinium; b.i.d.: twice daily; FF/GP: formoterol fumarate/glycopyrrolate.