Reuters is reporting that the Swedish Medical Products Agency has approved a fluticasone/salmeterol DPI manufactured by Greek pharmaceutical company Elpen. The approval apparently took place in May 2011 but was not announced. The company has not said when or if it will launch the product in European countries outside of Greece.
Elpen has been marketing the inhaler in Greece under the name Rolenium since late 2009 and has gained a 9% market share in that country. The product is delivered by the company’s Elpenhaler DPI, which uses a double aluminum blister strip. Two other Elpenhaler products — a generic formoterol inhaler and a generic fluticasone inhaler — are also marketed by the company in Greece. The company is also developing a generic budesonide/formoterol combination and a generic tiotropium DPI.
Reuters quotes a GSK spokesperson as being skeptical about the viability of the Elpenhaler device and suggesting that the generic version “would not be substitutable.”
Read the Reuters article.
