Hyderabad-headquartered drug major Aurobindo Pharma Limited has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market for Ondansetron Injections.
The approved Ondansetron Injections are the generic equivalent of GlaxoSmithKline’s Zofran injection and indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or postoperative nausea and/or vomiting, the company said in a filing to the exchange.
The products are ready for launch, it said.
These are the first ANDAs (abbreviated new drug applications) to be approved out of unit-IV formulation facility in Hyderabad for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC.
With this, Aurobindo now has a total of 169 ANDA approvals (143 final approvals including two from Aurolife Pharma LLC and 26 tentative approvals) from USFDA.
Aurobindo's scrip is currently trading at Rs 195.75 on the Bombay Stock Exchange, up 1.74% over the previous close of Rs 192.40.
