Furiex Pharmaceuticals Inc (FURX)

[surf1944]

6:45AM Furiex Pharmaceuticals confirms Takeda's (TKPYY) receipt of complete response letter from the FDA for alogliptin and fixed-dose combination alogliptin and pioglitazone (FURX) 19.58 : Co onfirmed that Takeda Pharmaceutical (TKPYY) issued a news release reporting that Takeda has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug applications for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone. Takeda recently provided post-marketing data from outside the U.S. and has been in discussions with the FDA. The FDA has requested additional data, which Takeda believes it can supply from post-marketing data from outside the U.S., as well as data from its ongoing clinical trial program. Takeda intends to immediately request a meeting with the FDA to determine the appropriate next steps and is committed to addressing outstanding issues. Currently, Furiex receives royalty payments from Takeda for the sale of these alogliptin products, trade names NESINA and LIOVEL, in Japan.