FDA Patches Error in Teva Generic Drug Yank
Published Date: 8/4/2025
Notice
Summary
The FDA fixed a previous announcement about Teva Pharmaceuticals pulling approval for 23 generic drug applications. This means some medicines made by Teva and others won’t be officially approved anymore, affecting patients and pharmacies. The correction clears up important details about when these changes happen and what it means for everyone involved.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
23 Generic Drug Approvals Withdrawn
The FDA corrected a notice that says approval was withdrawn for 23 abbreviated new drug applications. This means some medicines made by Teva Pharmaceuticals and others will no longer be officially approved, which can affect patients who take those drugs and pharmacies that dispense them. The correction clarifies timing and what the withdrawal means for everyone involved (notice originally published January 15, 2025).
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.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
Previous / Next Documents
Previous: 2025-14680, Proposed Submission of Information Collection for OMB Review; Comment Request; Annual Reporting (Form 5500 Series)
The Pension Benefit Guaranty Corporation (PBGC) wants to keep collecting yearly reports from pension plans to make sure everything’s on track. This affects companies and organizations that manage retirement plans, and they’re asking for your thoughts before the current approval expires in March 2026. No big changes or extra costs are planned, just a smooth continuation of the reporting process.
Next: 2025-14683, Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications
The FDA is officially pulling the plug on 39 drug approvals because the companies told them these medicines aren’t being sold anymore. This means those drugs won’t be available, and the companies won’t have to keep up with approval rules. If you’re a patient or pharmacist, don’t expect these drugs back anytime soon!