AstraZeneca gets DCGI marketing approval for Symbicort 320 for asthma and COPD

AstraZeneca Pharma India has received marketing authorisation from the Drug Controller General of India (DCGI) for Symbicort 20 mcg.  Symbicort 320 mcg is a fixed-dose combination drug comprising budesonide and formoterol fumarate dehydrate delivered through a special device. It is indicated for treatment of severe asthma and for patients with moderate to severe COPD with frequent symptoms and a history of exacerbations.


Symbicort is approved for use in 91 countries for the treatment of asthma and COPD. Results from AstraZeneca’s two major clinical studies have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbation. Similarly, in two 12-month studies in patients with COPD, Symbicort was superior to placebo, formoterol and budesonide regarding lung function and showed a significant reduction in the exacerbation rate compared with placebo and formoterol.

“Asthma and COPD are common and major causes of chronic morbidity impacting millions of patients in India. It is often not well controlled by existing treatments. Symbicort 320 mcg will offer physicians and patients another treatment option for severe asthma and for moderate to severe COPD, where high dosage is required,” said Dr. Anilda D’souza, Head –Medical Affairs & Regulatory, AstraZeneca India.

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