Asthma BiResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDBiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — TEVA PHARMS USA INC, approved 2026-04-23 (ANDA212212).
111,454 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.