AstraZeneca submits U.S. NDA for Zomig fast melt formulation

ASTRAZENECA SUBMITS U.S. NDA FOR ZOMIG FAST MELT FORMULATION AND HAS GAINED APPROVAL IN 13 EUROPEAN COUNTRIES AstraZeneca today announced it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its fast melt formulation of Zomig for the acute treatment of migraine. The tablet melts within seconds on the tongue and provides migraineurs with a more convenient method of relieving their migraine. The fast melt formulation of Zomig has been approved in 13 European countries this year following first approval in Sweden in the second half of 1999. "Being able to take an effective treatment without a glass of water, anytime and anywhere a migraine headache starts, is a big advantage for migraine sufferers," said Dr David Lee, Global Product Team Physician for Zomig. The Zomig fastmelt formulation is a valuable addition to the Zomig line which offers both physicians and patients the flexibility to treat this disabling disorder. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. For further information, please contact: Steve Brown, tel: +44 (0)20 7304 5033 Lucy Williams, tel: +44 (0)20 7304 5034 ------------------------------------------------------------ Please visit for further information The following files are available for download:

About Us

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: