Vanda’s New Suit Claims FDA Disregards Statutory Deadlines for NDA Decisions

Vanda Pharmaceuticals is once again suing HHS and the FDA, claiming that the agencies are using regulatory process to accomplish an “end run” around the timetable required by law in its efforts to obtain an approval or a hearing for a new indication for its drug Hetlioz (tasimelteon) as a treatment for insomnia.

The complaint explains that the FDA “has a non-discretionary duty under the Federal Food, Drug, and Cosmetic Act (FDCA) to either approve an NDA or publish notice of an opportunity for a hearing in the Federal Register within 180 days of the filing of the application.”

The company has also been pursuing a decision on a different sNDA for Hetlioz as a treatment for jet lag since October 2018, with a U.S. District Court for the District of Columbia judge ruling recently that the FDA has until March 5 to provide the company an answer.

Read Vanda’s complaint here.

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