In 1999, the FDA requested that AstraZeneca provide
information on the clinical efficacy of Prilosec® in the paediatric
population, as well as pharmacologic and clinical safety information. In response to the
FDA's request, AstraZeneca submitted the results of a clinical programme consisting
of five studies involving children one month to 16 years of age. AstraZeneca is pursuing
efforts to have these additional data included in the product labelling to provide
guidance on the use of Prilosec® in children.
Prilosec® is not currently indicated for use in
children. Prilosec® is indicated for treating certain acid-related conditions,
including gastroesophageal reflux disease (GERD), in adults.
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 $15.8 billion and leading
positions in sales of gastrointestinal, oncology, anaesthesia (including pain management),
cardiovascular, central nervous system (CNS) and respiratory products.
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Steve Brown
+44 (0)20 7304 5033
Lucy Williams
+44 (0)20 7304 5034
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Michael Olsson
+44 (0)20 7304 5087
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- The company received a written request from the FDA on July 1, 1999, for paediatric studies with Prilosec®, in accordance with the Federal Food, Drug and Cosmetic Act. The Act grants a six-month period of exclusivity after scheduled patent expiration to pharmaceutical manufacturers, which provide paediatric safety and efficacy data for certain medications.
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