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(RTTNews) – Akebia Therapeutics, Inc. (AKBA) Thursday announced an interim response from FDA to its Formal Dispute Resolution Request regarding the Complete Response Letter received in March 2022 for vadadustat for treatment for anemia due to chronic kidney disease in adult patients.
Akebia said it had a discussion with FDA in November for additional clarifying information from the Office of New Drugs, Center for Drug Evaluation and Research. Akebia expects to submit the requested information to the FDA in January 2023.
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