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Akebia: FDA Denies Formal Dispute Resolution, But Provides Company Path Forward For Vadadustat

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat

FDA denies formal dispute resolution for vadadustat, outlines path forward

Akebia Therapeutics’ formal dispute resolution request was denied by the Office of New Drugs of the FDA for vadadustat in the treatment of anemia due to for dialysis-dependent patients, according to a press release.However, the response letter provided a path forward for the company to resubmit the new drug application.

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