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CHMP rules against Sandoz’s Claritin equivalent

This article was originally published in The Tan Sheet

Executive Summary

Generics firm Sandoz should not be authorized to market loratadine 10 mg in European Union members because the drug's bioequivalence with its reference medicine - Schering-Plough's Claritin (Clarityne in the EU) - has "not been sufficiently demonstrated," according to the European Medicines Agency's Committee for Medicinal Products for Human Use. After the Netherlands granted the German company marketing authorization for the nonprescription antihistamine in 2001, Sandoz sought mutual recognition in other EU member states. CHMP's May 29 opinion recommends suspending Sandoz's loratadine authorizations in the Netherlands and other countries. The European Commission will decide the fate of Sandoz's product after considering CHMP's opinion. Sandoz said loratadine 10 mg "is not a top product" and it will comply with the EC's decision expected in the next few months

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