First EMA Nod For Generic Xarelto; Apotex Pulls Upkanz For Neurodegenerative Disease
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Accord Healthcare has garnered the first positive opinion recommending granting a pan-European marketing authorization for a generic version of rivaroxaban from the EMA’s CHMP. However, originator Bayer claims that no generic competition will be possible for another three years.