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Home » FDA Must Respond to Vanda Request for Answers on Drug Denial, Court Rules
FDA Must Respond to Vanda Request for Answers on Drug Denial, Court Rules
The FDA has until March 5 to provide an answer for Vanda Pharmaceuticals’ five-year quest to understand why the FDA denied the company’s supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) — filed in October 2018 — as a treatment for jet lag disorder, a federal judge has ruled.