Zydus Healthcare Gets CDSCO Panel Nod To Market Vilanterol, Glycopyrrolate, Fluticasone Metered Dose Inhaler

Published On 2023-10-13 12:30 GMT   |   Update On 2023-10-20 09:59 GMT
Advertisement

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.

Advertisement

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.

Also Read:Synokem Pharma Gets CDSCO Panel Nod to Study Dydrogesterone SR Tablet

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News