Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials. Ondansetron Injection USP, 2 mg/mL is the generic equivalent of GlaxoSmithKline's Zofran® Injection, 2 mg/mL. For the 12 months ending December 2009 U.S. sales of Ondansetron Injection USP, 2 mg/mL were approximately $58 million at Average Wholesale Price (AWP). A launch date for the product has not yet been set.
“The addition of an injectable drug to our product offering will enhance our ability to build our hospital-based business.”
"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 Ltd.," said Arthur Bedrosian, president and chief executive officer of Lannett. "The addition of an injectable drug to our product offering will enhance our ability to build our hospital-based business."
Bedrosian said the company has a product application pending at the FDA for a single-dose vial of Ondansetron Injection USP, 2 mg/mL; an approval is expected shortly.
Ondansetron Injection, USP 2 mg/mL is indicated for the prevention of postoperative nausea and vomiting and for the prevention of chemotherapy-induced nausea and vomiting.
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