FDA approves Lannett's ANDA for Ondansetron Injection

Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, announced today 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, Single-Dose Vials. Ondansetron Injection, USP, 2 mg/mL is the generic version of GlaxoSmithKline's Zofran Injection, 2 mg/mL. For the 12 months ending December 2009, Ondansetron Injection, USP, 2 mg/mL had U.S. sales of approximately $58 million at Average Wholesale Price. A launch date for the product has not been set.

“Ondansetron Injection is another product coming out of our joint venture with Wintac Ltd. and the second injectable product for which we filed an ANDA and received FDA approval”

"Ondansetron Injection is another product coming out of our joint venture with Wintac Ltd. and the second injectable product for which we filed an ANDA and received FDA approval," said Arthur Bedrosian, president and chief executive officer of Lannett. "The additional dosage form broadens our product offering and builds our presence in the injectable market."

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.