FDA RESPONDS TO ASTRAZENECA'S CITIZEN PETITION - FDA ALSO GRANTS APPROVAL FOR A GENERIC VERSION OF PULMICORT RESPULES

FDA RESPONDS TO ASTRAZENECA'S CITIZEN PETITION - FDA ALSO GRANTS APPROVAL FOR A
GENERIC VERSION OF PULMICORT RESPULES

On 18 November 2008, the US FDA responded to AstraZeneca's Citizen Petition
surrounding the company's concern about the approval of any generic version of
PULMICORT RESPULES® (budesonide inhalation suspension).  While the FDA agreed
with some of the company's concerns, other arguments in the Citizen Petition
were denied. 
AstraZeneca disagrees with several elements of the FDA's decision and is
considering its options to respond.   
Simultaneously, the FDA has granted approval for a generic version of
AstraZeneca's PULMICORT RESPULES.  The ongoing litigation brought by AstraZeneca
against Teva for patent infringement continues, with the court case to commence
on 12 January 2009. 
AstraZeneca has full confidence in the strength of its intellectual property
rights protecting PULMICORT RESPULES and will continue to vigorously defend and
enforce its intellectual property.  
Patents covering PULMICORT RESPULES expire in 2018 with pediatric exclusivity
extending to 2019.
About Pulmicort Respules
PULMICORT RESPULES is a preventive, maintenance asthma medicine indicated for
use in children 12 months to 8 years of age in the United States.  Full-year US
sales for PULMICORT in 2007 totalled $964 million, about 90 percent of which is
accounted for by PULMICORT RESPULES. 
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