
Zydus Healthcare has received approval from the Subject Expert Committee (SEC) operating under the Central Drug Standard Control Organization (CDSCO) to produce and market a fixed-dose combination (FDC) of the pulmonary drug Vilanterol Trifenatate, Glycopyrrolate, and Fluticasone Furoate in a metered dose inhaler. This endorsement followed the submission of Zydus Healthcare's proposal and a Phase III clinical trial study report on the FDC inhaler. These components are combined to manage chronic obstructive pulmonary disease (COPD) and related conditions. In its meeting on October 5, 2023, the SEC's expert panel reviewed the proposal and clinical trial data, subsequently recommending permission for the manufacturing and marketing of this FDC.
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