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Emezine FDA Approval Status

FDA Approved: No
Brand name: Emezine
Generic name: prochlorperazine
Dosage form: Transmucosal Tablets
Company: BioDelivery Sciences International, Inc.
Treatment for: Nausea/Vomiting

Emezine is a buccal tablet formulation of prochlorperazine maleate intended for the treatment of severe nausea and vomiting.

In March 2006, BioDelivery Sciences International, Inc. announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Emezine (prochlorperazine maleate) had not been approved.

Development timeline for Emezine

DateArticle
Mar  1, 2006BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification
Jul 20, 2005BDSI Announces Acceptance of Emezine NDA for Review By FDA
May  2, 2005BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting

Further information

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