Aurobindo Pharma 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 (ANDA 202599) and Ondansetron Injection USP 2mg/mL packaged in 4mg/2mL Single-dose Vials, Preservative-free (ANDA 202600).
Importantly, these are the first ANDA’s to be approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC. Further, these products are ready for launch.
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.
Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
