Oseni is the branded name under which the drugs will be sold 
and there is a black box warning relative to cardiovascular disease. The standalone drug, Alogliptin, has been studied in clinical trials which involved and has been considered safe so it appears when the combinations are prescribed, this is where the black box warnings come in to play. Takeda along with the approval is also required to submit a number of studies. BD
On January 25, The United States Food and Drug Administration announced the approval of three new drugs to treat Type 2 diabetes. All produced by Takeda Pharmaceutical Company, Alogliptin will be used as a standalone medication and sold under the brand name Nesina. The other two will be used in combination with other, currently used diabetes medications.
Alogliptin will also be used in combination with Metformin; one of the most common and widely prescribed oral treatments of the disease.
The brand name for this combination will be Kazano. Additionally, Alogliptin will be used in combination with Pioglitazone, the scientific name for Takeda's Actos brand of diabetes medication. The new combination will be sold under the brand name Oseni. There will warnings on the labels of these newly approved drugs.
http://www.examiner.com/article/fda-announces-approval-of-three-new-drugs-to-treat-type-2-diabetes
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