Watson Laboratories,a subsidiary of Watson Pharmaceuticals,has won FDA approval for its abbreviated new drug application(ANDA)for Budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL unit-dose ampoules.
Budesonide Inhalation Suspension is the generic equivalent to AstraZeneca's Pulmicort RESPULES,a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to eight years.
Watson considers launching the product in 2012 subject to obtaining a favorable outcome on an anticipated motion for a preliminary injunction in the pending litigation with AstraZeneca concerning the product.
Pulmicort RESPULES had total US sales of approximately$1.1bn according to IMS Health data,for the twelve months ending 31 May 2012.
