FDA declines to approve Takeda diabetes drug

Drug maker receives complete response letter for two drugs

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

A complete response letter means that the FDA has finished reviewing a drug approval application, but questions remain that preclude approval. In this case, the agency requested additional data about the drugs, which Takeda said it would supply from clinical trials.


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Comments

- 8:03 AM
prettyold says

Takeda drug Actos has been
Takeda drug Actos has been linked to bladder cancer and this is still being investigated by the FDA

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