According to Lupin, the FDA has approved its ANDA 0.5 mg/2 mL single dose ampules of budesonide inhalation suspension, a generic version of AstraZeneca’s Pulmicort Respules, for the treatment of asthma in children aged 12 months to 8 years.
Other companies with approved ANDAs for budesonide inhalation suspension 0.5 mg/2 mL include Apotex (licensed to Nephron), Cipla, Impax, Sandoz, and Teva.
Read the Lupin press release.
