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Novadel’s NitroMist Application Moves Forward With Complete Response

This article was originally published in The Pink Sheet Daily

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Executive Summary

The nitroglycerin NDA has an updated user fee date in early November.

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The company expects full approval for the 505(b)(2) product following completion of manufacturing validation commitments. Par will co-promote the product, which administers nitroglycerine to the oral mucosa.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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