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:3/23/2017)...  The U.S. Food and Drug Administration today granted ... adults and pediatric patients 12 years and older with ... not received prior chemotherapy. This is the first FDA-approved ... skin cancer. "While skin cancer is one ... form called Merkel cell cancer have not had an ...
(Date:3/23/2017)... and VANCOUVER, British Columbia , ... SPHS ) (the "Company" or "Sophiris"), a clinical ... of urological diseases, today announced that data from its ... drug as a focal treatment for localized prostate cancer, ... 2017 at the 32 nd Annual European Association ...
(Date:3/23/2017)... -- Research and Markets has announced the addition of ... their offering. ... The global oxygen therapy devices market to grow at a CAGR ... Global Oxygen Therapy Devices Market 2017-2021, has been prepared based on ... covers the market landscape and its growth prospects over the coming ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... ... serving the families and businesses of the Norwalk and Vermillion areas, celebrates ... Recovery Center (N.O.R.A.) is a nonprofit, community-based substance abuse prevention and peer ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... owned and organized by HMP Communications Holdings, LLC, today announced that RestorixHealth® ... its nationwide network of wound centers interested in becoming Certified Wound Specialist Physicians ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... and workflow solutions, today named The Resource Group as their 2016 Microsoft Dynamics ... partner conference in Newport Beach, CA. The award recognizes The Resource Group ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... supplements that help improve all aspects of people’s health and nutrition, announced its ... nutritional products. , Natural Subsistence develops nutritional supplements that help people improve ...
(Date:3/23/2017)... ... March 23, 2017 , ... The Leaders ... life-altering and fatal diseases in opposition to the President’s Fiscal Year 2018 ... care, services, and hope for the most vulnerable among us. , The proposed ...
Breaking Medicine News(10 mins):