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:2/12/2016)... -- Memorial Hermann Health System has teamed up with Houston ... a one-of-a-kind experience to pediatric patients at Children,s ... 360-degree video and Google Cardboard, Howard was able to ... the patients and their families an unexpected, and energetically ... video . Memorial Hermann IRONMAN Sports ...
(Date:2/12/2016)... 12, 2016  Aralez Pharmaceuticals Inc. (Nasdaq: ARLZ ... Company will ring the Nasdaq Closing Bell at the ... at 4:00 p.m. ET on Tuesday, February ... Adrian Adams , will perform the honorary ... 4:00 p.m. ET.  A live webcast will be available ...
(Date:2/12/2016)... 12, 2016 --> ... Chronic Inflammation Global Clinical Trials Review, H2, 2015 ... global clinical trials landscape along with top level ... Country (G7 & E7), Trial Status, Trial Phase, ... top companies involved and enlists all trials (Trial ...
Breaking Medicine Technology:
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... Lean Leadership Series at Zuckerberg San Francisco General Hospital on April 5-7. The ... new behaviors and create new habits. The workshops cover a broad range of ...
(Date:2/12/2016)... NC (PRWEB) , ... February 12, 2016 , ... AssureVest ... surrounding areas, is initiating a charity drive that will raise funds earmarked to purchase ... John C. Tayloe Elementary School. , “My school is in a low-income area and ...
(Date:2/12/2016)... , ... February 12, 2016 , ... ... the Pittsburgh metro area, celebrates the beginning of the latest charity campaign in ... social skills through art. Donations to this worthy cause are currently being accepted ...
(Date:2/12/2016)... ... February 12, 2016 , ... J Thomas & Associates ... it’s commitment to act as Agents of Change in the community, announces a ... homeless families to fulfill immediate needs and help them move into permanent housing. ...
(Date:2/12/2016)... ... February 12, 2016 , ... Homeowners ... exterior design possibilities. CertainTeed, North America’s leading brand of building products, has improved ... offerings showcased in the mobile version of the ColorView® Exterior Style and Color ...
Breaking Medicine News(10 mins):