Pulmicort

RNS Number : 4511I

AstraZeneca PLC

19 November 2008

 



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. 

Media Enquiries:
Chris Sampson	[phone] (24 hours)
Neil McCrae	[phone] (24 hours)
Investor Enquiries UK:
Jonathan Hunt	[phone]	mob: [phone]
Mina Blair	[phone]	mob: [phone]
Karl Hard	[phone]	mob: [phone]
Investor Enquiries US:
Ed Seage	[phone]	mob: [phone]
Jorgen Winroth	[phone]	mob: [phone]
Peter Vozzo (MedImmune)	[phone]	mob: [phone]

19 November 2008

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