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21 Jun 2017

A close look into AstraZeneca’s DCGI marketing approval for Symbicort 320 for asthma and COPD

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What is meant by DCGI approval?

Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization is responsible for approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.

About Symbicort – 

Budesonide/formoterol is a combination formulation containing budesonide and formoterol used in the management of asthma and chronic obstructive pulmonary disease (COPD). It contains two active ingredients delivered via a single inhaler.

Budesonide, an anti-inflammatory corticosteroid which acts by reducing and preventing respiratory tract inflammation.
Formoterol, a rapid-acting and long-lasting β2-agonist which acts by causing bronchodilation.

The formulation is marketed under various trade names, notably by AstraZeneca under the trade name Symbicort and others.

Budesonide/formoterol formulation was introduced in Sweden in 2000. It was not approved for use in the United States until July 2006. It is now approved for use in at least 91 countries, yielding global sales in excess of $1 billion in 2005, and now approximately $3.7 billion per annum.

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.

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