Emezine 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 Status and FDA Approval Process for Emezine
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.