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US health regulator has given final approval to Cipla, for a suspension product used for treating asthma.
Cipla in a BSE filing today stated, “it has received final approval for its abbreviated new drug application (ANDA) for Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL from the United States Food and Drug Administration (USFDA).”
The product which received approval, is a generic version of Astrazeneca’s Pulmicort Respules. Further, Pulmicort Respules are suggested for maintenance treatment of asthma and as prophylactic therapy in children of 12 months to 8 years.
