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11 September 2003
ASTRAZENECA SUBMITS NEXIUM® INTRAVENOUS FORMULATION TO FDA FOR REGULATORY APPROVAL

AstraZeneca today announced submission of the new Nexium® (esomeprazole sodium) intravenous (i.v.) formulation for regulatory approval by the US Food and Drug Administration (FDA).
The submission of the FDA package follows two weeks after the company received its first European approval for the i.v. formulation of the Proton Pump Inhibitor (PPI) Nexium from the Swedish Medical Products Agency (MPA). Further European launches will follow the conclusion of a Mutual Recognition Procedure in which Sweden will act as the reference member state.

In clinical studies, Nexium administered intravenously exhibited similar effects as oral Nexium. It is intended for patients suffering from gastroesophageal reflux disease (GERD) who are unable to take oral therapy due to their critical condition, such as those in intensive care units. The i.v. formulation is also an additional opportunity to expand the use of Nexium, which in 2002 had sales of $1.978 billion worldwide.



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