Leading products for Europe
With the full market approval of Efdege® ([18F] Fluorodeoxyglucose) in 15 EU countries in 2004, IASON achieved its first and biggest milestone as a pharmaceutical company.
Based on strong research focus, two further pharmaceuticals could be approved (IASOdopa® 2006 in four countries, IASOflu® 2009 in France, 2010 in 12 further countries) by 2009. With full market approval of IASOcholine® ([18F] Fluorocholine) in France in 2010, IASON succeeded in completing the next step. IASOcholine® is the first PET pharmaceutical worldwide, which obtained full market approval on the basis of an internal clinical study. IASOcholine® will initially be approved in four other EU countries and IASON will also aim at an approval procedure with the FDA (American Food and Drug Administration). Thus, IASON has taken the leading role worldwide as opinion leader with regard to the new approval of radiopharmaceuticals both on the market and towards the approval authorities.
With IASOdopa® ([18F] Fluordopa, in France, Germany, Austria and Italy) and IASOflu® (sodium [18F] fluoride), IASON is the first pharmaceutical company worldwide which has more than one approved product for PET. With these full market approvals, IASON has build up a leading competence in the area of regulatory affairs and is now considered to lead the way.