Pfizer gets EU approval for Relpax

Pfizer's migraine treatment Relpax (eletriptan hydrobromide), aselective 5-hydroxytryptamine receptor agonist that is effective in the acute treatment of migraine with or without aura and its associated symptoms, has completed the European Mutual Recognition Process, and non-European Union member states such as Norway have also agreed to recognize the earlier approval of the drug at doses of 20mg, 40mg and 80mg.

Relpax is currently approved in a number of countries worldwide, but the company has received two letters from the US Food and Drug Administration asking for an additional trial looking at cardiovascular physiology before it can complete its review of the drug, therefore it is uncertain when US approval may materialize (Marketletter December 18, 2000).