Regulatory proceedings blockbuster drug
February 2011 - On 8 February the Judicial division of the Council of State heared the appeal in the regulatory proceedings regarding the granting by the Dutch Medicines Evaluation Board ("CBG") of marketing auhtorisations for generic versions of the blockbuster drug Lexapro. As the Netherlands is the Reference Member State in the decentralised, European granting proceedings for these marketing authorisations, it all boils down to the decision of the CBG. We were successful in the earlier proceedings, when the District court of Haarlem nullified CBG's decision to suspend the marketing authorisations. In its new decision, the CBG reinstated the marketing authorisations. Lundbeck appealed. The oral hearing in the further appeal attracted a lot of international attention. BarentsKrans (Marleen van den Horst, Annemieke Kooy) represented two of the three generic manufacturers.
