FDA approves Cipla’s generic Pulmicort Respules

The Food and Drug Administration has approved Cipla’s generic of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). The drug is indicated as a maintenance treatment for asthma and as prophylactic therapy in children ages 12 months to 8 years. The Mumbai-based Cipla said the drug was available immediately for shipment.

Cipla’s generic will be available in dosage strengths of 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2ml. The product and its generics had U.S. sales of roughly $825 million for the 12 months ended September 2017, according to IQVIA data.