KAPIDEX to be marketed as DEXILANT in the U.S.

Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.

After receiving reports of dispensing errors between KAPIDEX and the products Casodex® (bicalutamide) and Kadian® (morphine sulfate extended-release), Takeda, in coordination with the U.S. Food and Drug Administration (FDA), determined that, in the interest of patient safety, a name change would be the best way to minimize future medication errors with KAPIDEX.

It is important to stress that the formulation, indication and approved dosages of DEXILANT will remain the same as KAPIDEX. Markings on the capsules will not change and their appearance will be identical to those marked under the KAPIDEX trade name. DEXILANT will have a new National Drug Code (NDC) number associated with the product. Takeda anticipates that the newly named product DEXILANT will be available toward the end of April 2010.

"Takeda's first priority is patient safety, which is why we initiated a widespread communications campaign to inform healthcare professionals and pharmacists as soon as we learned about the potential for confusion," said Robert Spanheimer, M.D., vice president of medical and scientific affairs at Takeda. "Recently, through discussions with the FDA, we agreed that the best way to minimize these dispensing errors was to change the trade name of dexlansoprazole to DEXILANT."

Takeda is currently working with the FDA to make this change and will conduct an extensive communications campaign to alert both patients and healthcare professionals of DEXILANT. Individuals and healthcare professionals who have questions about this name change should contact Takeda at 1-877-TAKEDA-7.  

"New medication names are extensively screened by Takeda prior to adoption to minimize the possibility of confusion once a drug is on the market. The FDA also conducts independent research to further minimize the risk of name confusion prior to acceptance and approval of a product brand name," said Dean Sundberg, senior vice president of regulatory affairs at Takeda. "Once marketed, however, instances of name confusion occasionally emerge."

Errors involving DEXILANT or any other products should be reported to the FDA MedWatch program online at www.fda.gov/medwatch.

SOURCE Takeda Pharmaceuticals North America, Inc.

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