Cipla receives US FDA approval for generic Pulmicort Respules

The drug is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age

Cipla 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 (US FDA) to market a generic version of Astrazeneca’s Pulmicort Respules.

Cipla’s Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL, are AN-rated generic equivalents of Astrazeneca’s Pulmicort Respules® and are indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. The product is available for shipping immediately. Pulmicort Respules and generic equivalents had US sales of approximately $825 million for the 12-month period ending September 2017, as reported by IMS Health.