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Aurobindo Pharma Ltd has received final approvals from the US Food and Drug Administration (USFDA) to manufacture and market Ondansetron Injection and Ondansetron Injection.
The approved products were the generic equivalent of GlaxoSmithKline’s Zofran injection and indicated for prevention of nausea and vomiting associated with initial and repeat course of emetogenic cancer chemotherapy or post-operative nausea, the Hyderabad-based company said in a release on Monday.
These were the first Abbreviated New Drug Applicatons to be approved out of Unit IV formulation facility in Hyderabad for manufacturing general liquid injectable and ophthalmic products.
They would be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, and were ready for launch, the release added.
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