News
FDA provides complete response letter for TAK 721 in eosinophilic esophagitis.
Takeda announced that it has received a Complete Response Letter from the FDA in response to its New Drug Application for TAK 721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis, a chronic inflammatory disease of the esophagus.
The CRL indicates the FDA has completed its review of the TAK 721 NDA and determined that it cannot be approved in its present form. In addition, the FDA recommended an additional clinical study in order to help resolve FDA feedback.
Condition: Eosinophilic Oesophagitis
Type: drug
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