FDA: Baclofen Oral Solution Safe, Generics Can Proceed
Published Date: 8/10/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Generics Can Still Reference OZOBAX
The FDA determined on August 10, 2026 that OZOBAX (baclofen) oral solution, 5 mg/5 mL (originally approved September 18, 2019 and discontinued by the holder on October 13, 2023) was not withdrawn for reasons of safety or effectiveness. FDA will not begin procedures to withdraw approval of ANDAs that refer to this product, and FDA may continue to approve new ANDAs that refer to it so long as they meet legal and regulatory requirements.
Discontinued but Not Pulled for Safety
The FDA has concluded that OZOBAX (baclofen) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. The product will remain in the Orange Book's "Discontinued Drug Product List" and FDA may continue approving ANDAs that refer to this product if they meet all legal and regulatory requirements.
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.
2026-19704, Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA just dropped a draft guide for companies making robot-assisted surgical devices, showing how to get their products approved before selling. If you’re in the biz, now’s the time to check it out and send your feedback by November 24, 2026. This guide aims to make the approval process clearer and smoother, potentially saving time and money down the road.
2026-19655, Jeffrey Thies: Final Debarment Order
Jeffrey Thies is banned for 10 years from importing any drugs into the U.S. because he was convicted of trafficking fake drugs. He didn’t respond to the FDA’s notice, so the ban started on September 25, 2026. He can apply to end the ban anytime, but until then, no drug imports for him!
Previous / Next Documents
Previous: 2026-16247, Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRINSUPRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Next: 2026-16253, Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0009
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0009, Oil Record Book for Ships; without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.