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TAK-721 FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 16, 2020.

FDA Approved: No
Brand name: TAK-721
Generic name: budesonide
Dosage form: Oral Suspension
Company: Takeda Pharmaceutical Company Limited
Treatment for: Eosinophilic Esophagitis

TAK-721 (budesonide oral suspension) is a novel mucoadherent topically active oral viscous formulation of budesonide in development as a treatment for eosinophilic esophagitis (EoE).

Development timeline for TAK-721

Sep 20, 2023Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
Dec 21, 2021Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721
Dec 15, 2020U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

Further information

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