Glenmark Gets CDSCO panel nod to market asthma, COPD drug
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New Delhi: Granting the waiver of bioequivalence study, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Glenmark Pharmaceuticals to manufacture and market the fixed dose combination drug (FDC) Fluticasone Furoate plus Vilanterol Trifenatate Dry Powder for inhalation.
This came after the Glenmark Pharmaceuticals presented the justification for bioequivalence (BE) study waiver along with in-vitro study data.
Fluticasone Furoate and Vilanterol Trifenatate Dry Powder for inhalation is a fixed drug combination medication used to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma and chronic obstructive pulmonary disease (COPD).Fluticasone furoate and Vilanterol trifenatate have prolonged retention in the lung with effects on lung function over 24-hours.It is indicated for the prevention and reduction of symptoms like wheezing and trouble breathing caused by asthma and ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema).
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