Zydus Healthcare Gets CDSCO Nod to study Fluticasone Furoate plus Vilanterol Trifenatate FDC
New Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct an active post-marketing surveillance (PMS) study of the pulmonary fixed-dose combination (FDC) drug, Fluticasone Furoate plus Vilanterol Trifenatate dry powder for inhalation in a capsule.
This came after the drug major Zydus Healthcare presented the active post-marketing surveillance (PMS) protocol before the committee.
Fluticasone furoate is an inhaled corticosteroid that can be used as maintenance treatment of asthma and/or chronic obstructive pulmonary disease (COPD) depending on the product. Also available as a nasal spray to manage symptoms of allergic rhinitis.
Fluticasone Furoate is used in the treatment of sneezing and runny nose due to allergies. Fluticasone Furoate is a steroid that works by blocking the production of certain chemical messengers in the body that cause inflammation (redness and swelling) and allergies.
Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). These medications work by relaxing and opening air passages in the lungs, making it easier to breathe.
At the recent SEC meeting for pulmonary drugs held on 4th January 2024, the expert panel reviewed the active PMS protocol of the FDC Fluticasone Furoate plus Vilanterol Trifenatate dry powder for inhalation in a capsule.
After detailed deliberation, the committee recommended granting permission to conduct the active PMS study.
In addition, the expert panel suggested that the firm should submit the active PMS study report to CDSCO for further review by the committee.
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