Posted by Michael Wonder on 20 Sep 2023
Takeda announces FDA acceptance of NDA resubmission of TAK-721 (budesonide oral suspension) for the short-term treatment of eosinophilic oesophagitis
20 September 2023 – Takeda today announced that the US FDA has accepted for review its new drug application resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic oesophagitis, a chronic inflammatory disease that can cause damage to the oesophagus.
The resubmission is intended to address previous FDA feedback to the Company’s original new drug application submission.
