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news.PPD, a global contract research organization, has confirmed that Takeda Pharmaceutical Company has submitted a new drug application to the FDA for marketing approval of alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.
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Under PPD’s agreement with Takeda, the submission of the new drug application for alogliptin and Actos does not trigger a milestone payment to PPD. If the new drug application (NDA) is approved by the FDA, PPD will be entitled to receive royalties on sales of this product.
Fred Eshelman, CEO of PPD, said: “We are very pleased with Takeda’s progression of the development of alogliptin/Actos. If approved by the FDA, this product would be the first type 2 diabetes treatment option that includes a DPP-4 inhibitor and a thiazolidinedione, or TZD.”