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DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.
Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.
The applications were submitted after the company received a complete response letter from the FDA for the drugs in April. A complete response letter means that the agency has finished reviewing an application, but questions remain that preclude final approval. Takeda's resubmissions include additional data from three phase-3 clinical trials that the FDA had requested.