AstraZeneca PLC
2 May 2001
ASTRAZENECA RECEIVES SIX MONTHS' MARKET EXCLUSIVITY
FOR PRILOSEC
AstraZeneca today announced that the US Food and Drug Administration (FDA)
granted six months' market exclusivity for Prilosec (omeprazole), after the
company complied with the FDA's formal request for information on the use of
the prescription medication in children. The additional six months'
exclusivity will be added to all of the relevant patents for Prilosec.
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.
Further Enquiries to:
Media Relations:
Steve Brown: Tel +44 (0)20 7304 5033
Investor Relations:
Michael Olsson: Tel +44 (0)20 7304 5087
Ed Seage: Tel: +44 (0)20 7304 5100
Jorgen Winroth: Tel +1 609 896 4148
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.