Name Change Approved for Heartburn Drug Kapidex

Emma Hitt, PhD

March 04, 2010

March 4, 2010 — The brand name of the heartburn drug dexlansoprazole (Kapidex, Takeda Pharmaceuticals North America Inc) has been changed to Dexilant, the US Food and Drug Administration (FDA) announced today.

Dexlansoprazole was approved in January 2009 and since that time dispensing errors have been reported resulting from confusion with the medications bicalutamide (Casodex, AstraZeneca) and morphine sulfate (Kadian, Actavis Kadian LLC).

"Sometimes unexpected name confusions can occur once the product goes to market," the FDA states in a press release.

Recently, the FDA issued a new guidance document for industry, "Contents of a Complete Submission for the Evaluation of Proprietary Names." The document describes the information that should be submitted to help in the evaluation of a proposed proprietary drug or biologic name and helps ensure compliance with other requirements for labeling and promotion.

The new guidance is part of the agency's Safe Use Initiative, launched in November 2009, which aims to reduce preventable medical errors through collaboration with public and private institutions.

"There will be no changes made to Kapidex other than its name," the FDA notes. "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."

Dexlansoprazole is listed as one of 27 drugs and drug categories being monitored for possible safety issues because of its name by the FDA's Adverse Event Reporting System , as reported earlier by Medscape Medical News. The new name change appears to be the FDA's resolution to the problem.

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

Adverse events related to dexlansoprazole should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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