Zydus Healthcare Gets CDSCO Panel Nod To Market Vilanterol, Glycopyrrolate, Fluticasone Metered Dose Inhaler
New Delhi: Pharmaceutical major, Zydus Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination (FDC) of the pulmonary drug Vilanterol Trifenatate plus Glycopyrrolate plus Fluticasone Furoate metered dose inhaler.
This came after Zydus Healthcare presented its proposal and a Phase III clinical trial study report of the FDC Vilanterol Trifenatate plus Glycopyrrolate plus Fluticasone Furoate inhaler before the committee.
Inhaled glycopyrrolate treats air flow blockage and prevents the worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (difficulty with breathing).
Vilanterol is a long-acting beta2-adrenergic agonist used in combination with other bronchodilators for the management of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone is a corticosteroid indicated in the treatment of corticosteroid-responsive dermatoses, asthma, and COPD.
The combination of fluticasone and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma and chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema) in adults.
At the recent SEC meeting for pulmonary held on 5th October 2023, the expert panel reviewed the proposal presented by Zydus Healthcare along with the Phase III clinical trial study of the FDC Vilanterol Trifenatate plus Glycopyrrolate plus Fluticasone Furoate inhaler.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the proposed FDC.
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