New Delhi: The drug major Zydus Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the pulmonary drug combination Vilanterol tridentate 12.5mcg plus Glycopyrrolate 25mcg metered dose inhalation.
This came after Zydus Healthcare presented its proposal along with the Phase III clinical trial report before the committee.
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. Its pharmacological effect is attributable to stimulation of intracellular adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increases in cyclic AMP are associated with the relaxation of bronchial smooth muscle and inhibition of the release of hypersensitivity mediators from mast cells in the lungs.
Glycopyrrolate, also known as glycopyrronium, is an anticholinergic drug. Glycopyrronium is used to treat hyperhidrosis, severe drooling, COPD, used with other medications to treat ulcers, and used in anesthesia. Glycopyrrolate is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy. Glycopyrrolate injection is also used during surgery to reduce secretions in your stomach or airway and to help protect your heart and nervous system while you are under general anesthesia.
Glycopyrrolate's primary mechanism of action is the blockage of acetylcholine's effects at the parasympathetic sites in various tissues. This blockage primarily occurs in the central nervous system, smooth muscle, and secretory glands. It also reduces the rate of salivation by preventing the stimulation of the acetylcholine receptors themselves.
At the recent SEC meeting for the Pulmonary held on 7 November 2023, the expert panel reviewed the proposal along with the Phase III clinical trial report of the pulmonary drug combination Vilanterol tridentate plus Glycopyrrolate metered dose inhalation.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the proposed FDC.
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