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).
Fluticasone Furoate is an inhaled corticosteroid that can be used as maintenance treatment of asthma and/or chronic obstructive pulmonary disease (COPD). It is also used to manage symptoms of allergic rhinitis. It is a synthetic glucocorticoid used as an inhaler and nasal spray for various inflammatory indications.Fluticasone furoate works through a mechanism to affect the action of various cell types and mediators of inflammation.
Vilanterol is a selective long-acting beta 2-adrenergic agonist (LABA) with inherent 24-hour activity for once daily treatment of COPD and asthma. It stimulates intracellular adenylyl cyclase and catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). This increase in cyclic AMP is associated with relaxation of bronchial smooth muscles and inhibition of release of hypersensitivity mediators from mast cells in the lungs.
At the recent SEC meeting for Pulmonary held on 7th June 2022, the expert panel reviewed the justification for BE study waiver and in-vitro study data of the FDC Fluticasone Furoate plus Vilanterol Trifenatate Dry Powder for inhalation in detail.
After detailed deliberation, the committee recommended for grant of permission to manufacture and market the proposed FDC with the condition that Active PMS study should be conducted.
In addition, the committee directed the firm that Active Post-marketing Surveillance (PMS) study protocol should be submitted by the firm within 03 months for further review by the committee.
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