March 22, 2021
Takeda Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
New Drug Application for Oral Disintegrated Tablet Formulation of TAKECAB® for Treatment of Acid-Related Disease
- Takeda has applied for approval of TAKECAB® OD 10 mg and TAKECAB® OD 20 mg as additional formulations of TAKECAB® 10 mg and TAKECAB® 20 mg, developed by Takeda for treating acid-related disease
Takeda Pharmaceutical Co., Ltd. (Takeda) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that Takeda has applied for approval to manufacture and market TAKECAB® OD 10 mg and TAKECAB® OD 20 mg as additional formulations of TAKECAB® 10 mg and TAKECAB® 20 mg, developed by Takeda for treating acid-related disease.
The application for approval is based on a human bioequivalence study conducted in Japan (TAK-438ODT-1001) and dissolution tests.
TAKECAB OD tablets are suitable for patients with impaired swallowing, including elderly patients, and the increase in treatment options can also be expected to improve medication adherence. Based on a domestic co-promotion agreement concluded in 2014, Takeda will manufacture and sell TAKECAB OD tablets, with informational activities conducted jointly by Otsuka and Takeda.
Information in this news release was current as of the original release date.