Cipla gets FDA approval for generic Pulmicort Respules to treat asthma
New Delhi: Drug major Cipla said it has received final approval from the US health regulator for a suspension product used for the treatment of asthma.
In a BSE filing, Cipla said, "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 approved product is a generic version of AstraZeneca's Pulmicort Respules, it added.
Pulmicort Respules is indicated for maintenance treatment of asthma and as prophylactic therapy in children of 12 months to 8 years.
Citing IMS Health data, Cipla said Pulmicort Respules and generic equivalents had US sales of approximately USD 825 million for the 12 months to September 2017.