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