Aurobindo Pharma gets USFDA nod for nausea injections
New Delhi: Drug firm Aurobindo Pharma Monday said 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.
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, Aurobindo Pharma said in a statement.
"The products are ready for launch," it added.
The injections are the generic equivalent of GlaxoSmithKline's Zofran injection, Aurobindo Pharma said.
"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.
These are the first abbreviated new drug applications (ANDAs) to be approved out of the company's Unit IV formulation facility in Hyderabad and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, Aurobindo Pharma said.
The company now has a total of 169 ANDA approvals (143 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals), it added.
Shares of Aurobindo Pharma were Monday trading at Rs 194.55 per scrip on BSE, up 1.12 percent from its previous close.