 "DCGI grants approval for AstraZeneca's inhaler to treat asthma")
AstraZeneca Pharma India Ltd has received the approval of Drug Controller General of India (DCGI) for marketing its asthma drug Symbicort Turbuhaler in the country. The product contains two active ingredients in one inhaler - budesonide (320 µg) and formoterol (9 µg).
“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,” said BSE on June 15, 2017.
Symbicort Turbuhaler, a product of AstraZeneca global, is indicated in the regular treatment of asthma where use of combination of inhaled regular corticosteroid & long acting beta-agonist is appropriate and patients with moderate to severe COPD (chronic obstructive pulmonary disease) with frequent symptoms and a history of exacerbations.
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