Cipla Ltd, a global pharmaceutical company announced that 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) 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 U.S. sales of approximately $825M for the 12- month period ending September 2017, as reported by IMS Health.
About Cipla Ltd.
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. In the last 80+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 80 countries. Our portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally. Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla’s emphasis on access for patients was recognised globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla’s research and development focuses on developing innovative products and drug delivery systems.