Taro Pharmaceutical Industries, a multinational, science-based pharmaceutical company, specializing in discovery, development, manufacturing and marketing of healthcare products, has received FDA approval for its abbreviated new drug application for Granisetron Hydrochloride tablets USP, 1mg (base) (granisetron tablets).
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Taro Pharma’s Granisetron tablets is a prescription product used for the prevention of nausea and vomiting associated with chemotherapy and radiation treatment and is bioequivalent to Hoffman-La Roche’s Kytril tablets, 1mg (base).
Granisetron Hydrochloride is selective 5-HT 3 receptor antagonists. Serotonin receptors of the 5-HT 3 type are located peripherally on vagal nerve terminals, enteric neurons in the GI tract, and centrally in the chemoreceptor trigger zone.
During chemotherapy, mucosal enterochromaffin cells from the small intestine release serotonin, which stimulates the 5-HT 3 receptors. This evokes vagal afferent discharge, inducing vomiting. Clearance is predominantly by hepatic metabolism, and plasma protein binding is approximately 65%.
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