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
Further information
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