Vanda Pharmaceuticals Inc. (VNDA) said on Friday that the U.S. Food and Drug Administration (FDA)’s re-review of the clinical hold on long-term clinical studies of Tradipitant in motion sickness has been extended.
The FDA was initially expected to complete the re-review on November 26 and has since then extended it to December 5 to accommodate the leadership shift at the Center for Drug Evaluation and Research, the company said.
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