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:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation ... and home sensors for real-time monitoring of patients with ... nonprofit organization focused on disruptive health solutions for rare ... system to record and integrate behavioral, cognitive, physiological and ... ...
(Date:9/25/2017)... --  Montrium , an industry leader in powerful ... Trial Master Files & Inspection Readiness Conference ( ... Services has selected eTMF Connect to ... a leading European contract research organization (CRO), will ... enable greater collaboration with sponsors, improve compliance and ...
(Date:9/22/2017)... Sept. 22, 2017  As the latest Obamacare repeal ... Bill Cassidy (R-LA) and Lindsey Graham ... the medical device industry is in an odd place. ... the 2.3% excise tax on medical device sales passed ... want covered patients, increased visits and hospital customers with ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... to meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s ... experts and tested to meet the highest standard. , These products are ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... Mohebi Hair Restoration, has recently contributed a medical article to the newly revamped ... cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular ...
(Date:10/12/2017)... ... 12, 2017 , ... Health Literacy Innovations (HLI), creator of ... and the Cancer Patient Education Network (CPEN), an independent professional organization that shares ... strategic alliance. , As CPEN’s strategic partner, HLI will help support CPEN ...
Breaking Medicine News(10 mins):