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FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
Date:1/30/2009

dle acid than the esophagus. If the esophagus is continually exposed to stomach contents, damage to the lining of the esophagus such as breaks or lesions can occur, a condition known as erosive esophagitis (EE).

About KAPIDEX (dexlansoprazole) delayed release capsules

KAPIDEX (dexlansoprazole) delayed release capsules, previously known by the development code TAK-390MR, is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. KAPIDEX combines an enantiomer of lansoprazole with a Dual Delayed Release(TM) (DDR) formulation designed to provide two separate releases of medication. KAPIDEX, taken once-daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Important Safety Information

KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy. The most commonly reported treatment-emergent adverse reactions (greater than or equal to 2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. KAPIDEX should not be co-administered with atazanavir. KAPIDEX may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time.

Please see the complete prescribing information and visit the KAPIDEX Web site at
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SOURCE Takeda Pharmaceuticals North America, Inc.
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