ARTICLE | Clinical News

Spiriva Respimat tiotropium bromide regulatory update

September 29, 2014 7:00 AM UTC

FDA approved an NDA from Boehringer for inhaled Spiriva Respimat tiotropium bromide for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations. Boehringer plans to launch the bronchodilator delivered via the Respimat Soft Mist Inhaler in January. FDA approved the product under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...