FDAnews Drug Daily Bulletin

FDA RESCINDS APPLICATION APPROVAL FOR ZOFRAN ODT

Dec. 9, 2005
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The FDA has rescinded approval of Par Pharmaceutical's abbreviated new drug application (ANDA) for a generic version of GlaxoSmithKline's (GSK) anti-nausea treatment Zofran ODT.

The agency's action came after the Center for Drug Evaluation and Research learned that the U.S. District Court for the District of New Jersey ruled that Par's ANDA infringes GSK's patent on Zofran ODT (ondansetron HCl orally disintegrating tablets). The patent is not due to expire until Dec. 24, 2006.

The FDA recently approved Par's ANDA for ondansetron in 4- and 8-mg dosage strengths. At the time, Par said it expected to launch its product no later than December 2006, but could start marketing the product earlier depending on the outcome of its ongoing patent litigation with GSK.

In July, the U.S. District Court for the District of New Jersey issued a summary judgment ruling that GSK's '628 patent and '789 patent for Zofran ODT are valid, enforceable and infringed by Kali's product. Kali is appealing the decision. The '628 method of use patent expired Aug. 16, and the '789 method of use patent expires Dec. 24, following expiration of pediatric exclusivity.