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Zensana Approval Status

FDA Approved: No
Brand name: Zensana
Generic name: ondansetron hydrochloride
Dosage form: Oral Spray
Company: Hana Biosciences
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Zensana (ondansetron hydrochloride) is an oral spray 5-HT3 antagonist formulation intended for the prevention of chemotherapy induced nausea and vomiting.

In March 2007, Hana Biosciences announced its plan to withdraw, without prejudice, its pending NDA for Zensana with the FDA.

Development Status and FDA Approval Process for Zensana

DateArticle
Aug  1, 2007Par Pharmaceutical Licenses North American Rights to Zensana from Hana Biosciences
Aug 30, 2006FDA Accepts for Review NDA Filing for Zensana (Ondansetron HCl) Oral Spray
Jun 30, 2006Hana Biosciences Submits Zensana NDA to the FDA
May  9, 2006Hana Biosciences Reaffirms Expected Timing of First NDA Filing

Further information

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