Aurobindo gets US FDA final approval for Ondansetron orally disintegrating tabs
Aurobindo Pharma Limited has received the final approval for Ondansetron Orally Disintegrating tablets (IDT) USP 4mg and 8mg from the US Food and Drug Administration (US FDA).
Ondansetron ODT 4mg and 8mg are the generic equivalent GlaxoSmithKline's Zofran ODT 4mg and 8mg. Ondansetron ODTs are antiemetics and indicated for prevention of nausea and vomiting in patients undergoing chemotherapy, radiation therapy or surgery. The product is ready for launch.
Aurobindo has total of 115 ANDA approvals (86 final approvals and 29 tentative approvals) from US FDA.