Cipla gains 3% on final approval for generic Pulmicort Respules

The company has received final approval from the USFDA to market a generic version of Astrazeneca's Pulmicort Respules.

Cipla was up 3.4% to Rs 613 on the BSE in intra-day trade after the pharmaceutical company announced that it has received a final approval from the US health regulator for generic Pulmicort Respules used for treatment of asthma.

“The company 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) to market a generic version of Astrazeneca’s Pulmicort Respules,” Cipla said in a press release.

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, it added.

As reported by IMS Health, Pulmicort Respules and generic equivalents had U.S. sales of approximately $825 million for the 12-month period ending September 2017.