New Proton Pump Inhibitor - Regulatory Application
ASTRAZENECA PLC
21 October 1999
ASTRAZENECA SUBMITS FIRST REGULATORY APPLICATION FOR ITS NEW PPI VIA
EUROPEAN MUTUAL RECOGNITION
AstraZeneca today announced that a regulatory application for
H199/18, a new proton pump inhibitor (PPI), has been submitted to
authorities in Sweden, acting as rapporteur country in the European
Union's mutual recognition procedure. The new pharmaceutical
contains the active substance esomeprazole.
This marks the first step in a global application process, which
will be followed by applications in the USA, among other countries.
'H199/18 is the first PPI synthesised as an isomer to be available
for clinical use, and it is a further evolution in PPI therapy
beyond omeprazole', said Dr Martin Nicklasson, Executive Vice
President of AstraZeneca's GI Franchise. 'This is a significant
milestone for AstraZeneca's business in the gastrointestinal area.'
21 October 1999
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