Tasimelteon

An agreement with the FDA will see Vanda Pharmaceuticals pause or dismiss several of its lawsuits against the agency. Vanda Pharmaceuticals and the FDA have agreed to lay down their swords, squashing years of legal disputes with an agreement that will see regulatory action on much of Vanda’s grievances.The “collaborative framework” comes after Vanda chalked up a win against the agency in an August D.C. appeals court decision. After the company took its fight to market its sleep disorder med Hetlioz in jet lag disorder to court, the appeals court scratched a recent FDA refusal of the indication and determined that the agency’s treatment of Vanda’s clinical trial evidence was “cursory.”  Now, Vanda will get another chance to put its jet lag application on the FDA’s desk. The agency agreed to an expedited re-review of the label expansion bid by Jan. 7, 2026, Vanda said in a press release. During the re-review, the two will pause proceedings stemming from Vanda’s recent appeals court win.An official re-review has been a long time coming. The FDA had initially issued a complete response letter on the indication all the way back in 2019, then left the application pending for years as it delayed Vanda’s repeated requests for hearings on the matter.Elsewhere in its agreement with the FDA, the agency pledged to conduct a separate sped-up re-review of a longstanding partial clinical hold that prevents Vanda from studying its drug candidate tradipitant in motion sickness for more than 12 weeks. The agency will meanwhile continue reviewing the drug in the proposed indication, upholding the decision date of Dec. 30, 2025, that was set in March.Vanda had previously described the Dec. 30 action date as an example of a “broken, unaccountable FDA,” considering that the date would be 12 months after Vanda’s initial submission.On Vanda’s end, the company will put the brakes on much of its active litigation against the FDA. Vanda’s “administrative proceedings” before FDA Commissioner Marty Makary, M.D., on its bid for a tradipitant approval in gastroparesis will be paused temporarily until Jan. 7, 2026. The drugmaker also agreed to pause its lawsuit that challenges the FDA for taking up to 12 months rather than the standard 180 days to decide on new drug applications. Meanwhile, Vanda will dismiss two other lawsuits against the FDA outright, which involve the tradipitant partial hold and a label request for Hetlioz in jet lag disorder.A period of peace between Vanda and the FDA marks new ground after years of exchanging barbs in the courts. Most recently, the company slammed “FDA bureaucrats,” who, according to Vanda, blamed a hearing delay on tradipitant’s approvability on staffing cuts in the Center for Drug Evaluation and Research and presented “a new scapegoat” in Makary.