Conduct Phase III CT: CDSCO Panel Tells Zydus Healthcare on Glycopyrrolatem plus Indacaterol metered dose inhalation
New Delhi: Considering the bioequivalence study report presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm conduct the Phase III clinical trial of the fixed dose combination (FDC) pulmonary drug Glycopyrrolate plus Indacaterol Maleate metered dose inhalation.
This came after Zydus Healthcare presented a bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver before the committee.
Indacaterol and glycopyrrolate combination is used as long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty breathing). Indacaterol and glycopyrrolate are long-acting bronchodilators.
Glycopyrronium, also known glycopyrrolate, is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications.
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