Holzkirchen, Germany, January 14, 2014 - Sandoz announced today it has received Swedish marketing authorization for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and COPD.
The product was first approved in Denmark on December 18th, 2013. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device. On January 13, 2014 Sandoz also received marketing authorization for AirFluSal® Forspiro® in Germany.
Sweden has approved the 50-500 µg and 50-250 µg dosage forms 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 receipt of the marketing authorizations in Sweden, Germany and Denmark follows the successful completion of EU decentralized procedures also including Norway for the 50-500 µg and 50-250 µg dosage forms and for the 50-500 µg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania . We look forward to bringing this product to patients across these markets and we will communicate as and when we receive further market approvals.
About Sandoz Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz employs over 26,000 employees in more than 140 countries, offering broad range of over 1,000 high-quality, affordable products that are no longer protected by patents. With USD 8.7 billion in sales in 2012, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology and antibiotics as well as strong positions in the treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003 , Sandoz has benefitted from strong growth of its acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).