NovaDel’s New Drug Application For ZolpiMist Oral Spray To Treat Insomnia Accepted For Filing By The U.S. Food And Drug Administration
NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for ZolpiMist? (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines.
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