Glenmark gets CDSCO Panel nod to study Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation
Glenmark
New Delhi: In line with the revised Phase IV clinical trial protocol of Glycopyrronium 50 mcg plus Fluticasone Furoate 100 mcg plus Vilanterol 25 mcg Powder for Inhalation, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Glenmark for conducting the Phase IV clinical trial of the proposed FDC.
In addition, the committee recommended that the firm submit the Phase IV clinical trial report to CDSCO for further review by the committee.
This came after the firm presented the proposal along with the revised Phase IV clinical trial (CT) protocol before the committee.
Glycopyrronium bromide belongs to a group of medicines called “anticholinergics”. These medicines help to prevent the formation of secretions that can cause problems in the respiratory tract. Glycopyrrolate, or glycopyrronium bromide, inhibits parasympathetic nerve impulses by selectively blocking the binding of acetylcholine to muscarinic receptors.
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