FDA Opens Meeting on REXULTI Drug Updates for Mental Health
Published Date: 6/17/2025
Notice
Summary
The FDA is holding a public meeting to talk about a new request for REXULTI (brexpiprazole) tablets, a medicine that helps with mental health. They want to hear from everyone before making decisions, so patients, doctors, and drug makers should pay attention. This could change how REXULTI is used and might affect treatment options soon.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-19419, Sanjay Kumar: Final Debarment Order
Sanjay Kumar is banned for 5 years from importing any drugs into the U.S. because he was convicted of a serious crime involving fake goods. He didn’t respond to the FDA’s notice, so the ban starts on September 23, 2026. He can apply to end the ban anytime, but must follow special rules to keep info private.
2026-19349, Nonclinical Testing Terminology
The FDA wants to update its rules by swapping out the word “animal” tests for “nonclinical” tests to better reflect modern science. This change affects drug safety testing rules, encourages new testing methods that might use fewer animals, and doesn’t add any new costs or requirements. Anyone interested can comment on these changes until December 7, 2026.
Previous / Next Documents
Previous: 2025-10988, Trinity Capital Inc., et al.
Trinity Capital and its partners want permission to team up and invest together in certain companies, even though current rules usually say no. This change would let business development companies and related investment groups pool their money for bigger opportunities. If no one objects by July 7, 2025, the SEC will likely say yes—potentially opening doors for smarter, joint investments without extra costs.
Next: 2025-10990, Internal Revenue Service Advisory Council; Public Meeting
The IRS Advisory Council is hosting a public meeting to discuss important tax topics that affect everyday taxpayers and businesses. This is a chance to hear about possible changes and improvements in how taxes are handled, with updates that could impact your money and filing process soon. Stay tuned and get ready to engage with the folks shaping tax rules!