Sandoz receives first approval for AirFluSal Forspiro

Novel inhaler approved for patients with asthma and COPD Approval follows completion of EU decentralized procedure (DCP) AirFluSal Forspiro strengthens Sandoz respiratory portfolio and reinforces company leadership in differentiated products Munich, December 18, 2013 - Sandoz announced today that it has received Danish marketing authorization for AirFluSal Forspiro , an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). The Danish approval follows the completion of EU decentralized procedures (DCP) for eight EU countries, including Denmark. AirFluSal Forspiro offers the proven combination of salmeterol (a long-acting inhaled ß2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative new inhalation device. The product's safety, efficacy and equivalence have been proven in multiple clinical trials , . Denmark has approved both mid and high-strength dosage forms (50-250µg and 50-500µg) for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. "The first approval of AirFluSal Forspiro is a key element of our strategy to introduce differentiated generic medicines," said Jeff George, Global Head of Sandoz.