indacaterol maleate/budesonide / Zydus Lifesciences - LARVOL DELTA

Zydus Gets CDSCO Panel Nod To Conduct Phase IV Trial For Indacaterol-Budesonide FDC Inhalation (Medical Dialogues) - "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....After detailed deliberation, the committee recommended for grant of permission to conduct of the Phase IV clinical trial."

New P4 trial • Asthma • Chronic Obstructive Pulmonary Disease

Zydus Healthcare gets CDSCO panel nod for study of Indacaterol, Budesonide Inhaler (Medical Dialogues) - "The Subject Expert Committee (SEC) under the Central Drugs Control Standard Organization (CDSCO) has shown a green light to Zydus Healthcare to conduct a phase III study of respiratory drug combination Indacaterol maleate plus Budesonide dry powder for inhalation and inhaler. However the permission comes with the condition that the survey include more government sites."

New P3 trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases