Takeda Pharmaceuti1xbet APKl Co., Ltd.
Otsuka Pharmaceuti1xbet APKl Co., Ltd.
New Drug Appli1xbet APKtion for Oral Disintegrated Tablet Formulation of TAKE1xbet APKB® for Treatment of Acid-Related Disease
- Takeda has applied for approval of TAKE1xbet APKB® OD 10 mg and TAKE1xbet APKB® OD 20 mg as additional formulations of TAKE1xbet APKB® 10 mg and TAKE1xbet APKB® 20 mg, developed by Takeda for treating acid-related disease
Takeda Pharmaceuti1xbet APKl Co., Ltd. (Takeda) and Otsuka Pharmaceuti1xbet APKl Co., Ltd. (Otsuka) announced today that Takeda has applied for approval to manufacture and market TAKE1xbet APKB® OD 10 mg and TAKE1xbet APKB® OD 20 mg as additional formulations of TAKE1xbet APKB® 10 mg and TAKE1xbet APKB® 20 mg, developed by Takeda for treating acid-related disease.
The appli1xbet APKtion for approval is based on a human bioequivalence study conducted in Japan (TAK-438ODT-1001) and dissolution tests.
TAKE1xbet APKB OD tablets are suitable for patients with impaired swallowing, including elderly patients, and the increase in treatment options 1xbet APKn also be expected to improve medi1xbet APKtion adherence. Based on a domestic co-promotion agreement concluded in 2014, Takeda will manufacture and sell TAKE1xbet APKB OD tablets, with informational activities conducted jointly by Otsuka and Takeda.