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Q: US Pharmaceutical Drug Filings with FDA ( Answered,   0 Comments )
Question  
Subject: US Pharmaceutical Drug Filings with FDA
Category: Health > Medicine
Asked by: coisty1690-ga
List Price: $10.00
Posted: 29 Jun 2005 08:55 PDT
Expires: 29 Jul 2005 08:55 PDT
Question ID: 538333
I got Emend for nausea and vomiting when undergoing chemotherapy
recently. I am had an operation recently and they were not able to
offer this great drug. Do you know if Merck filed an NDA for Emend for
Post-operative Nausea and vomiting?
Answer  
Subject: Re: US Pharmaceutical Drug Filings with FDA
Answered By: scriptor-ga on 29 Jun 2005 09:30 PDT
 
Dear coisty1690,

Merck's drug Emend is listed in the FDA Drug Database under the FDA
Application No. (NDA) 021549. The drug was approved by the FDA on 26
March 2003.

The Consumer Drug Information Sheet filed with the FDA describes the
purpose of Emend as follows:

"Emend is an antiemetic medicine for use in adult patients. An
antiemetic is a medicine used to prevent and control nausea and
vomiting. Emend is always used with other medicines to prevent and
control nausea and vomiting caused by your chemotherapy treatment.
Emend is not used to treat nausea and vomiting that you already have."

However, treatment of post-operative nausea and vomiting is not
mentioned anywhere in the filed descriptions or the drug approval
entry. The Emend label, approved by the FDA on 9 June 2005, does not
list post-operative usage either, only treatment in connection with
chemotherapy as described above. So it is most likely that there is no
FDA approval for using Emend to treat post-operative nausea and
vomiting.

I hope this answers your question!
Regards,
Scriptor


Sources:

U.S. Food and Drug Administration: Catalog of FDA Approved Drug Products - Emend
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=EMEND

U.S. Food and Drug Administration: Emend Consumer Drug Information Sheet
http://www.fda.gov/cder/consumerinfo/druginfo/emend.htm

U.S. Food and Drug Administration: FDA approved Emned Label (PDF file)
http://www.fda.gov/cder/foi/label/2005/021549s009lbl.pdf
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