Strativa submits NDA for generic Zofran ODT
US drugmaker Strativa has submitted a New Drug Application for its new, orally-dissolving film strip formulation of ondansetron to the Food and Drug Administration. Strativa is seeking approval of 8mg and 4mg strengths for the prevention of chemotherapy- and radiation-induced nausea and vomiting, as well as prevention in the post-operative setting.
A program consisting of three separate pivotal studies comparing the bioequivalence of ondansetron ODFS 8mg to UK drug major GlaxoSmithKline's branded Zofran ODT 8mg was completed in December 2008 and supports the NDA filing of Strativa's product. The pharmacokinetic results of each study demonstrate that a single dose, taken with or without water, is bioequivalent to Zofran ODT when taken under similar conditions, the US firm noted.
The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95%.
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