Advisory Committee meetings are discussions of pending applications and other public health matters. The FDA frequently convenes its panel of outside experts to provide guidance and recommendations; however, the recommendations of the committee are not a final decision. The FDA will evaluate the committee's decision and their final recommendations will follow.

Takeda remains committed to ACTOS and to the millions of people living with type 2 diabetes. Takeda is the inventor and developer of ACTOS, which was launched commercially in the U.S. in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Since its launch, more than 100 million ACTOS family prescriptions have been written, covering more than 10 million patients. In clinical trials using ACTOS in monotherapy, the most common adverse events (greater than or equal to 5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus, and pharyngitis.

SOURCE Takeda Pharmaceuticals North America, Inc.