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Aug31
USFDA Accepts Hana Biosciences' New Drug Application For Zensana Oral Spray
Gloria Gamat August 31, 2006
Know More: Drug Regulations & Approval
The USFDA has accepted a New Drug Application submitted by Hana Biosciences (HNAB), the North American partner of NovaDel Pharma (NVD) for Zensana™ (ondansetron HCl) Oral Spray.

The NDA was filed under Section 505(b)(2) of the Food, Drug and Cosmetic Act. If approved by the FDA, Hana targets commercial launch of Zensana™ in the United States in the first half of 2007.

NovaDel is due an additional milestone payment upon product approval, and royalties on the sales of the product. NovaDel retains worldwide rights to Zensana™ outside of North America.

Source: Novadel via BusinessWire

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« Millenium Pharmaceuticals Initiates Phase I Trials for MLN0415 Drug Candidate Against Inflammatory Diseases | Main | European Commission Approves Novartis' Exjade Oral Iron Chelator »

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