For Immediate Release
2013.12.20
Mitsubishi Tanabe Pharma Corporation
Daiichi Sankyo Co., Ltd.
TENELIA® 20mg tablets, a Treatment for Type 2 Diabetes Mellitus Approval of Partial Change in Indication to Lift Restrictions in Combination Therapy
OSAKA and TOKYO, Japan, December 20, 2013---Mitsubishi Tanabe Pharma Corporation (hereafter, Mitsubishi Tanabe Pharma; President & CEO: Michihiro Tsuchiya) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo; President & Representative Director: Joji Nakayama) announced today that Mitsubishi Tanabe Phama has received approval of a partial change in indication for TENELIA® 20mg tablets (generic name: Teneligliptin hydrobromide hydrate) for the treatment of type 2 diabetes mellitus.
Based on the approval of the partial change, the indication of TENELIA® has changed to "type 2 diabetes mellitus" based on the "Guideline for Clinical Evaluation of Oral Hypoglycemic Agents", and TENELIA® is now available for combination therapy with existing oral hypoglycemic agents, such as biganides,