According to Cipla, the company’s ANDA for generic budesonide inhalation suspension has been approved by the FDA for the treatment of asthma in children aged 12 months to 8 years.
Cipla will market the generic version of Pulmicort Respules in 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL strengths, with product available for shipping immediately.
Read the Cipla press release.