Navigation Links
FDA Approves Name Change for Heartburn Drug Kapidex
Date:3/4/2010

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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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 http://www.fda.gov/medwatch.

For more information

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

http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm

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

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075068.pdf

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

http://www.fda.gov/downloads/Drugs/DrugSafety/MedicationErrors/ucm080867.pdf

Media Inquiries: Elaine Gansz Bobo, 301-796-7567; elaine.bobo@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Back to top

RELATED LINKS
http://www.fda.gov/

'/>"/>

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:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 26, 2016 ... care operating models within the health care industry is ... financial efficiency , Deloitte offers a suite of ... business issues impacting efficient cost optimization: labor resource analysis, ... These services facilitate better outcomes and better economics ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... 2016 Research and Markets ... Electronics 2015-2025: Applications, Technologies, Forecasts" report to ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, Composite ... Structural electronics involves electronic and/or electrical components and ... dumb structures such as vehicle bodies or conformally ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic ... World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. ... some of the world’s leading providers of cereal and other breakfast foods. Its residents ...
(Date:6/26/2016)... ... 2016 , ... PawPaws brand pet supplements owned by Whole Health ... the health of felines. The formula is all-natural and is made from Chinese herbs ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
Breaking Medicine News(10 mins):