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Zensana is an oral spray containing the anti-emetic compound, ondansetron in it. Zensana is the first spray that provides patients with the opportunity of gaining and maintaining protection from chemotherapy, radiation and induced nausea and vomiting. Zensana is usually used and most beneficial for people who cannot use anti-emetics therapy for controlling their bouts of nausea and vomiting through tablets.
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NovaDel signed a 20 year license with Hana biosciences for rights to the development of regulatory and commercialization activities of Zensana in America on October 2004. It was in the year 2006 that Hana Biosciences completed clinical trials on the bioequivalence and bioavailability of Zensana. This was when it also filed its NDA to the Food, Drug and Cosmetic Act.
Hana Biosciences then announced plans for withdrawal on March 23, 2007 without any prejudice at anyone, its pending NDA for Zensana with the FDA. This was done with the intention of redirecting development plans that were meant for Zensana through NovaDel’s patient protection of its European formulation.
It is based on the successful scale up and manufacturing tests of the European formulation of NovaDel’s ondansetron that Hana Biosciences decided on conducting the right clinical trials, and then to re-file NDA for Zensana in the year 2008.in a bid to maintain their rights and hold in the drug market for Zensana, NovaDel has retained all rights for the oral spray ondansetron in the outside market of north America. In the meantime, it is also pursuing commercial partners for these markets.
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