AstraZeneca gets DCGI node for marketing asthma drug in India

Mumbai: AstraZeneca has received the approval for marketing its asthma drug Symbicort Turbuhaler in India from Drug Controller General of India (DCGI).

“AstraZeneca Pharma India Limited has received import and market permission in Form 45 (Marketing Authorization) from the Drug Controller General of India for FDC (fixed dosage combination) of budesonide and formoterol fumarate dihydrate inhalation powder,” the company stated in a BSE filing on June 15, 2017.

FDC of Budesonide 320 μg + Formoterol Fumarate Dihydrate 9 μg inhalation powder (Symbicort® Turbuhaler® 320/9 μg) is a product of AstraZeneca global and is indicated in the regular treatment of Asthma where use of combination of inhaled regular corticosteroid & long acting β-agonist is appropriate and patients with moderate to severe CORD with frequent symptoms and a history of exacerbations.