Glenmark Pharmaceuticals Europe said that its marketing authorization application for a generic version of Seretide Accuhaler (Advair Diskus) for the treatment of asthma and COPD has been approved through the decentralized procedure in the Nordic region, making the fluticasone/salmeterol DPI the company’s first inhaled product approved by European authorities.
In 2015, Glenmark announced that it had acquired rights from Celon to develop and market the DPI in 15 countries, including the UK, Germany, Romania, and the Nordic countries. According to the company, this is the first approval deriving from that deal.
Glenmark Pharmaceuticals Limited Chairman Glenn Saldanha said, “Our successful registration closure of a complex respiratory product like fluticasone/salmeterol dry powder Inhaler (DPI) in a developed market re-enforces Glenmark’s capability and determination towards the respiratory segment. This continues to emphasize Glenmark’s focus in this complex product segment and in Europe. We will continue to work in the area of respiratory especially devices in Europe and we will continue to launch products in this area in future.”
Read the Glenmark press release.