Drug news
FDA responds to Takeda's NDAs for Type 2 Diabetes therapies Nesina and combination Nesina and Actos
The FDA has provided a complete response letter to Takeda regarding its NDAs for Type 2 Diabetes drugs Nesina (alogliptin) and Actos (fixed-dose combination alogliptin and pioglitazone). This combination therapy is now being sold in Japan under the brand name Liovel. Takeda is set to request a meeting with the FDA to determine the appropriate next steps. Recently, Takeda provided postmarketing data from outside the US, and has been in discussion with the FDA. The FDA has requested additional data which Takeda believes it can supply to the Agency from postmarketing data from outside the US, as well as data from its ongoing clinical trial program.
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