Aurobindo Pharma gets USFDA nod

Pharmaceutical company Aurobindo Pharma said on Monday that it has received final approval from the US health regulator to manufacture and market Ondansetron injections and is ready to launch the products in the US market.

In a statement, it said, “The company has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Ondansetron injection USP 2rng/mL packaged in 40mg/20mL multiple-dose vials and Ondansetron injection USP 2mg/mL packaged in 4mg/2mL single-dose vials.

The products are ready for launch.” The injections are the generic equivalent of GlaxoSmithKline’s Zofran injection.

“The injections are indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or postoperative nausea and/or vomiting,” it added.

The company said it now has a total of 169 ANDA approvals (143 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals).
The stock price of the company closed at Rs 194.20 on the Bombay Stock Exchange on Monday, up 0.94 per cent from its previous close.

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