Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Lannett Company has received FDA approval for its abbreviated new drug application (ANDA) for Ondansetron injection USP, 2mg/ml, Multi-Dose Vials, the generic equivalent of GlaxoSmithKline’s Zofran injection, 2mg/ml.
Subscribe to our email newsletter
Ondansetron injection, USP 2mg/ml is indicated for the prevention of postoperative nausea and vomiting and for the prevention of chemotherapy-induced nausea and vomiting.
Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.
Arthur Bedrosian, president and CEO of Lannett, said: “Ondansetron injection is the first injectable product for which Lannett has filed an ANDA and, importantly, the first product candidate approved for marketing from our joint venture with Wintac. The addition of an injectable drug to our product offering will enhance our ability to build our hospital-based business.
“The company has a product application pending at the FDA for a single-dose vial of Ondansetron injection USP, 2mg/ml; an approval is expected shortly.”