News
16 Feb 2015
Actavis Launches Generic Pulmicort Respules
Actavis has launched its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a ruling from the US District Court for the District of New Jersey that (i) US Patent No. 7,524,834 is invalid, and (ii) AstraZeneca's request for a permanent injunction is denied.
Actavis' Abbreviated New Drug Application (ANDA) for its generic version of Pulmicort Respules received final approval from the FDA in August 2012.
Pulmicort Respules is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended June 30, 2014 total US brand and generic sales of Pulmicort Respules were approximately $1.1 billion.
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