FDA allows Teva's Pulmicort to AZ's protests

The US Food and Drug Administration has granted Israeli generics giant Teva approval to market a generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension), despite the Anglo-Swedish drug major's protests.

AstraZeneca had sent a Citizen Petition to the FDA detailing its concerns over the approval of any generic version of the drug. While the firm notes the FDA agreed with some of its concerns, other arguments in the Petition were denied and the approval went ahead.

AstraZeneca says it is currently considering its options to respond and the ongoing litigation against Teva for patent infringement continues, with the court case to commence in January 2009. Patents covering the product expire in 2018 with pediatric exclusivity extending to 2019, it says.