Glenmark Gets CDSCO panel nod for Phase IV CT of COPD drug
New Delhi: Pharmaceutical major, Glenmark has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol.
However, this approval is subjected to a condition that the follow-up of the study should be up to 06 months, the details of the last visit including the test parameters should be mentioned in 6th month and telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation.
Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.
Glycopyrrolate and formoterol are long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.
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