Munich, Germany, February 28, 2014 - Sandoz announced today it has received South Korean marketing authorization for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and COPD, marking its first approval in Asia.
The product was first approved in Denmark on December 18th, 2013, with subsequent approvals in Germany, Belgium, Sweden, Norway, Hungary, Romania and Bulgaria.
“We are pleased to receive the marketing authorization in South Korea for AirFluSal® Forspiro®. This is our first approval in Asia and outside Europe and a milestone in our strategy of bringing our innovative inhaler to more patients across the world,” said Jan-Torsten Tews, Head of Sandoz’s Global Respiratory Franchise.
AirFluSal® Forspiro® is Sandoz’s high-quality innovation to help treat the growing number of asthma and COPD patients worldwide. 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.
Visual control features which help reassure the patient about dosing
Simple lever arm to load the dose
Clear and accurate dose counter
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. It is displayed in design museums in Essen and Singapore.
South Korea has approved the 50/250 and 50/500µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD.
About Sandoz Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees across more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics. 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, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).