Lannett Ondansetron injection receives FDA approval

Anti-nausea drug rubberstamped by US regulator.

Lannett, a company that develops, manufactures and distributes generic prescription pharmaceutical products in tablet, capsule and oral liquid forms, has been granted approval for its abbreviated new drug application (ANDA) for Ondansetron injection USP, 2mg/ml, single-dose vials by the FDA.

Ondansetron injection USP, 2mg/ml, indicated for the prevention of postoperative nausea and vomiting and for the prevention of chemotherapy-induced nausea and vomiting, is the generic version of Zofran injection, 2mg/ml of GlaxoSmithKline.

Ondansetron injection is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic. Its effects are thought to be on both peripheral and central nerves.

Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone.

Arthur Bedrosian, president and CEO of Lannett, said: "Ondansetron injection is another product coming out of our joint venture with Wintac and the second injectable product for which we filed an ANDA and received FDA approval."