Novartis Receives Approval in Japan for Onbrez Inhalation Capsules
Novartis has received approval in Japan for Onbrez Inhalation Capsules for the treatment of chronic obstructive pulmonary disease.
Novartis announced that it has received approval in Japan for Onbrez Inhalation Capsules (indacaterol) 150 mcg once-daily for the treatment of chronic obstructive pulmonary disease (COPD).
Onbrez, delivered using the Breezhaler device, belongs to the long-acting beta2-agonist (LABA) class of medicines which help to reduce the symptoms of breathlessness, cough and sputum in COPD patients by increasing bronchodilation, or airflow into the lungs. The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Onbrez for relief of symptoms due to airway obstruction in COPD (chronic bronchitis and emphysema).
The submission was supported by a clinical trial program that included three local clinical studies. The pivotal 12-week Phase III study showed that Onbre
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