USFDA gives final approval to Cipla’s anti-asthma product

Drug major Cipla today said it has received final approval from the US health regulator for a suspension product used for treatment of asthma.

In a BSE filing today, 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 are 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.

Stock of Cipla was trading 3.11 per cent higher at Rs 611.45 on the BSE today.