Hyderabad-based, Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (FDA) 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). The 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.
These are the first ANDAs 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.
Aurobindo now has a total of 169 ANDA approvals (143 Final approvals including 2 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.
Aurobindo Pharma Limited 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.