Zydus Healthcare Gets CDSCO panel Nod To Market Vilanterol, Glycopyrrolate FDC metered dose inhalation

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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