NovaDel to receive milestone payment for FDA acceptance of Zensana NDA

By Elaine Rigoli

Tampa, Fla., Aug. 30 - NovaDel Pharma Inc. said Wednesday that the Food and Drug Administration has accepted for review the New Drug Application for Zensana (ondansetron HCl) oral chemotherapy spray, which was submitted by Hana Biosciences Inc., NovaDel's North American partner for ondansetron oral spray.

This acceptance triggers the next payment in a series of milestone payments to NovaDel.

"The Zensana development cycle, via the 505(b)(2) regulatory pathway, has been very time- and cost-efficient, generating multiple milestone opportunities for NovaDel in a short period while providing a rapid commercialization strategy. In addition, Zensana represents a near-term royalty opportunity for NovaDel based on potential product approval and launch by Hana in 2007," NovaDel president and chief executive officer Jan Egberts said in a company news release.

NovaDel is a specialty pharmaceutical company located in Flemington, N.J.

Hana is a South San Francisco, Calif.-based biopharmaceutical company.

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