Sandoz, the generic pharmaceuticals division of Novartis, 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. "This innovative new respiratory device underscores Novartis's commitment to asthma and COPD patients and further strengthens Sandoz' global leadership in differentiated products, which comprised 43 per cent of our sales in 2012."
AirFluSal Forspiro was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Centre of Excellence. Sandoz collaborated with UK-based Vectura, a respiratory product development company, in the design and development of the product. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.
In order to improve patient experience with inhalation devices, Sandoz collaborated closely with patients during the development of AirFluSal Forspiro. The device features an innovative, patient-friendly design, including multiple feedback mechanisms: visual control features which helps reassure the patient about dosing; simple lever arm to load the dose; clear and accurate dose counter.
Sandoz is a global leader in the rapidly growing generics industry.