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Takeda Announces the New Drug Application Approval of TAKELDA®Combination Tablets, the Fixed Dose Combination of TAKEPRON® and Low-Dose Aspirin, in Japan

March 24, 2014

Osaka, Japan, March 24, 2014 --- Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application of TAKELDA® Combination Tablets [a fixed dose combination (FDC) of low-dose aspirin and TAKEPRON® (generic name: lansoprazole) for peptic ulcers].

TAKELDA Combination Tablets combine 100 mg aspirin with 15 mg lansoprazole and are the first FDC drug in Japan to combine low-dose aspirin with a proton pump inhibitor.

The number of patients taking low-dose aspirin for prevention of the recurrence of cerebral infarction or myocardial infarction is increasing along with the rapidly aging population in Japan. It is well known that the administration of low-dose aspirin may cause the gastric and duodenal ulcers, therefore, prevention of an onset of ulcers in the said patient population is important. Domestic and international guidelines recommend combined administration with a proton pump inhibitor, especially for patients with a history of gastric or duodenal ulcer.

While TAKEPRON already has an approved indication for prevention of the recurrence of ulcers in patients who require administration of low-dose aspirin for a longer period while preventing the onset of ulcers. However, making it a FDC drug has made it more convenient and helps prevent patients from missing a dose, which will enable patients to take low-dose aspirin over the long term while controlling the occurrence of ulcers.

Takeda will continue to strive to provide patients and medical practitioners with highly convenient therapeutic options, while working to improve drug adherence among patients.

Patients actively participate in the decision-making of treatment courses or policies, and the treatment is implemented and continued accordingly.

Risk reduction of thrombosis and embolism in patients with a history of gastric ulcer or duodenal ulcer, who have below conditions.
- In patients who have had angina (chronic stable angina and unstable angina), myocardial infarction, and ischemic cerebrovascular disease [transient ischemic attack (TIA), cerebral infarction]
- In patients who have had coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA)
Dosage and Administration
Usually, for adults, one tablet (100 mg/15 mg as aspirin/lansoprazole) is orally administered once a day.

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