Cipla receives final approval for generic Pulmicort Respules

17 Nov 2017 Evaluate

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 (USFDA) 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.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally. 


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