Pharmaceutical Business review

FDA approves Watson ANDA for Budesonide inhalation suspension

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.