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news.Aurobindo Pharma, an India-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received final approval for Ondansetron Orally Disintegrating tablets (ODT) USP 4mg and 8mg from FDA.
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Ondansetron is the generic equivalent GlaxoSmithKline’s Zofran ODT. It is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting, often following chemotherapy. Its effects are thought to be on both peripheral and central nerves.
Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone. It has little effect on vomiting caused by motion sickness, and does not have any effect on dopamine receptors or muscarinic receptors.
Aurobindo Pharma said that the product is ready for launch. Currently, Aurobindo has a total of 115 ANDA approvals (86 final approvals and 29 tentative approvals) from FDA.