Takeda wins FDA approval for self-administered, subcutaneous Entyvio in ulcerative colitis
The FDA has approved a subcutaneous version of Takeda’s ulcerative colitis drug Entyvio, more than three years after rejecting the company’s application over what it said were issues related to the design and labeling of the device.
The drug will be available as a single-dose pre-filled pen by the end of October. It’s approved for use after induction therapy with intravenous Entyvio (vedolizumab), Takeda announced Wednesday.
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