Vanda Pharmaceuticals (VNDA) said, on September 18, the FDA declined to approve New Drug Application of tradipitant for the treatment of symptoms in gastroparesis, providing the company with a Complete Response Letter. Vanda said it will continue to pursue the marketing authorization for tradipitant and will continue to support the expanded access program.
Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard with a favorable benefit risk profile for the treatment of patients with gastroparesis.
Shares of Vanda Pharmaceuticals are down 10% in pre-market trade on Thursday.
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