Navigation Links
FDA Approves Name Change for Heartburn Drug Kapidex

Change to Dexilant is part of FDA effort to prevent medication errors

SILVER SPRING, Md., March 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.


Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.

Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain.

"The FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient safety," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The FDA evaluates new drug names before a product is approved to minimize confusion with existing drugs. Sometimes unexpected name confusions can occur once the product goes to market.

To improve this safety process, the FDA has issued a new guidance for industry titled Contents of a Complete Submission for the Evaluation of Proprietary Names. The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic name, and to ensure compliance with other requirements for labeling and promotion.

These efforts are part of the agency's Safe Use Initiative which was launched in November 2009. The goal of this initiative is to reduce preventable medical errors through collaboration with public and private institutions.

There will be no changes made to Kapidex other than its name. Health care professionals and other individuals responsible for ordering, stocking, and billing for the product should be aware that Dexilant will have a new National Drug Code (NDC) number associated with the product.

Individuals and health care professionals who have questions about the name change should contact Takeda at 877-TAKEDA-7.

Medication errors involving Dexilant or any other medications should be reported to the FDA's MedWatch program online at

For more information

FDA Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medications

Guidance for Industry – Contents of a Complete Submission for the Evaluation of Proprietary Names

Drug Topics FDA Safety Pages – How FDA Reviews Proposed Drug Names

Media Inquiries: Elaine Gansz Bobo, 301-796-7567;

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Back to top



SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
2. FDA Approves First New Inhaled Antibiotic for CF in More Than a Decade
3. FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinsons Disease
4. FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
5. FDA Approves Xiaflex for Debilitating Hand Condition
6. FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
7. Chinese State Food and Drug Administration Approves Company Facility for Producing Solid Dosage Perindopril
8. FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
9. FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
10. FDA Approves Lillys ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults
11. FDA Approves Lillys Zyprexa for Two Adolescent Indications
Post Your Comments:
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
(Date:11/26/2015)... , Nov. 26, 2015 Research ... addition of the "2016 Future Horizons and ... (TDM) Market: Supplier Shares, Country Segment Forecasts, Competitive ... --> --> ... analysis of the Italian therapeutic drug monitoring market, ...
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... European Cell Surface Marker Testing Market: ...  report to their offering.  --> ... addition of the  "2016 Future Horizons ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... On November 10, 2015, Bohrer Brady, LLC filed a ... behalf of a home health care worker who provided companionship services for the elderly, ... workers employed by Humana, Inc., Humana at Home, Inc., and SeniorBridge Family Companies (CT), ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article published November ... more widely heralded as a breakthrough for performing hernia repairs. The article explains that ... surgery is that it can greatly reduce the pain that a patient might otherwise ...
(Date:11/25/2015)... OH (PRWEB) , ... November 25, 2015 , ... Dental ... implants in Cleveland, OH , are invited to attend Dr. Mark Iacobelli’s Advanced Implant ... this year in Cleveland, OH. , As the co-founders of Advanced Implant Mentoring ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... athletic programs, launches new Wimbledon Athletics Facebook page to educate the ... for unsuspected cardiac abnormalities. About 2,000 people under the age of 25 die ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 23rd 2015 Cozy Products, ... personal heating products business. Cozy Products explains what this means for business moving forward. ... with the Cozy Products business model: to sell personal heaters that reduce energy consumption, ...
Breaking Medicine News(10 mins):