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Xeloda Generic Version Gets FDA Approval

Printed From: TNBC Foundation
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Forum Name: Let's Talk About Chemotherapy
Forum Description: A place to discuss Chemotherapy
URL: http://forum.tnbcfoundation.org/forum_posts.asp?TID=11519
Printed Date: Mar 26 2026 at 11:31pm
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Topic: Xeloda Generic Version Gets FDA Approval
Posted By: 123Donna
Subject: Xeloda Generic Version Gets FDA Approval
Date Posted: Sep 17 2013 at 2:57pm
Teva’s Generic Version of Xeloda Gains FDA Approval For Metastatic Colorectal And Breast Cancers
The U.S. Food and Drug Administration (FDA) approved the first generic version of Xeloda today, granting Teva Pharmaceuticals USA approval to market generic capecitabine in two strengths: 150 milligrams and 500 milligrams. The oral chemotherapy pill is used to treat colorectal cancer that has spread to other parts of the body (‘metastatic’) as well as metastatic breast cancer.
http://www.medicaldaily.com/tevas-generic-version-xeloda-gains-fda-approval-metastatic-colorectal-and-breast-cancers-256932" rel="nofollow - http://www.medicaldaily.com/tevas-generic-version-xeloda-gains-fda-approval-metastatic-colorectal-and-breast-cancers-256932


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DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15




Replies:
Posted By: 123Donna
Date Posted: Mar 11 2014 at 7:46am
Teva Launches Generic Xeloda Tablets
http://www.empr.com/teva-pharmaceuticals/manufacturer/11545/" rel="nofollow - Teva Pharmaceuticals  announced the launch of Capecitabine Tablets, the generic equivalent to  http://www.empr.com/genentech-inc/manufacturer/11390/" rel="nofollow - Genentech's   http://www.empr.com/xeloda/drug/2094/" rel="nofollow - Xeloda . Teva is the first company to receive approval for its ANDA for Capecitabine Tablets
Capecitabine is available in 150mg and 500mg strength tablets

http://www.empr.com/teva-launches-generic-xeloda-tablets/article/337496/" rel="nofollow - http://www.empr.com/teva-launches-generic-xeloda-tablets/article/337496/


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DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15




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