Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats Stage III colon cancer as a single agent. Sold as Xeloda. Every FDA application for this active ingredient: 1 branded and 14 generic.
As of Nov 15, 2026, FDA lists 15 applications for Capecitabine (sold as Xeloda), first approved Apr 30, 1998, with 13 new uses approved and 0 published complete response letters.
First approved: Apr 30, 1998
Applications: 15
New uses approved: 13
Complete response letters: 0
Medicare spending, 2025: $4.0M
First approved in the EU: Feb 2, 2001
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Capecitabine
Part B
$3.9M
+85040%
20,936
Capecitabine
Part D
$54K
+53%
42
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
CAPECITABINE 150 MG TABLET: $0.362 per unitGeneric · -9% in a year
CAPECITABINE 500 MG TABLET: $0.454 per unitGeneric · -10% in a year
Approvals in the EU (EMA)
First approved in the EU 33 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
XelodaA drug with a new dosage indicated for the treatment of unresectable or recurrent breast cancer and colorectal cancer. · Chugai Pharmaceutical Co., Ltd. · Nov 27, 2020
XelodaA drug with a new additional indication and a new dosage for adjuvant chemotherapy for rectal cancer. · Chugai Pharmaceutical Co., Ltd. · Aug 26, 2016
XelodaA drug with a new additional indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer. · Chugai Pharmaceutical Co., Ltd. · Feb 23, 2011
XelodaA drug with a new additional indication and a new additional dosage and administration for combination therapy with other anticancer drugs (XELOX + BV… · Chugai Pharmaceutical Co., Ltd. · Sep 18, 2009
Clinical Trials
872 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Accord Hlthcare
Hikma
Eugia Pharma