Sandoz, the German-based, generic pharmaceuticals division of Novartis, has received Danish marketing authorization for AirFluSal Forspiro, an inhaler that treats patients with asthma and/or COPD. The Danish approval follows the completion of EU decentralized procedures (DCP) for eight EU countries, including Denmark.
According to the company, AirFluSal Forspiro offers the combination of salmeterol (a long-acting inhaled ?2-agonist) and fluticasone (an inhaled corticosteroid) in one inhalation device. The product’s safety, efficacy, and equivalence have been proven in multiple clinical trials, according to the company.
The device features patient-friendly design elements, including visual control features that help reassure the user about dosing, a simple lever arm to load the dose, and a clear and accurate dose counter.
Denmark has approved both mid- and high-strength dosage forms (50-250µg and 50-500µg) for the continuous treatment of patients older than 12 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.”
The product is not approved for use by the U.S. Food and Drug Administration.