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.