Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation
New Delhi: In response to the proposal presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug maker to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Indacaterol maleate plus Budesonide Powder for inhalation (capsules).
In addition, the committee recommended the firm to submit the Phase IV clinical trial report of the FDC Indacaterol maleate plus Budesonide Powder for inhalation.
This came after the firm presented the Phase IV clinical trial protocol before the committee.
Indacaterol is a long-acting β2-adrenoceptor agonist and bronchodilator with a rapid onset of action. It was developed by Novartis. It is used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.
Budesonide is a glucocorticoid that acts as an anti-inflammatory and immunomodulator. Budesonide inhalation is a treatment for asthma and chronic obstructive pulmonary disease (COPD).
At the recent SEC meeting, the expert panel reviewed the Phase IV clinical trial protocol before the committee.
After detailed deliberation, the committee recommended for grant of permission to conduct of the Phase IV clinical trial. "Accordingly, the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee," the Panel noted.
