FDA approves Tudorza Pressair ( Forest Pharma) for COPD - 25-Jul-2012

The FDA on 23 July 2012 approved Tudorza Pressair (aclidinium bromide) from Forest Pharma for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years.

Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories. The drug submitted by Almirall has CHMP recommendation as Eklira for the EU.