FDA Pulls Approval on 72 Discontinued Generic Drug Applications
Published Date: 9/24/2025
Notice
Summary
The FDA is officially pulling the plug on 72 drug approvals because the companies said they stopped selling those medicines. This means those drugs won’t be available anymore, but no one’s losing money or access unexpectedly since the companies chose to stop marketing them. If you’re involved with these drugs, now’s the time to update your records and plans!
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
72 Generic Drug Approvals Withdrawn
The FDA is withdrawing approval of 72 abbreviated new drug applications (ANDAs). The companies told the FDA the products were no longer marketed and asked for the approvals to be withdrawn, so those medicines will no longer be available.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
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.
2026-13820 — Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that TOVALT ODT tablets (5 mg and 10 mg) weren’t taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions, making it easier and cheaper for people who need this sleep aid. If approved, more affordable options could hit the shelves soon, helping patients and saving money.
2026-13778 — Medical Device User Fee Amendments; Public Meeting; Request for Comments
The FDA is planning a public meeting on August 5, 2026, to talk about renewing fees that medical device makers pay to help speed up device reviews from 2028 to 2032. This affects companies making medical devices and could impact how much they pay and how fast their products get approved. The current fee program ends in September 2027, so the FDA wants your thoughts before finalizing new rules and fees.
2026-13716 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The FDA just updated the rules for new animal drugs, approving several new and generic medicines for pets and farm animals from early 2026. These changes help keep animal treatments safe and effective, and the updates take effect right away on July 7, 2026. If you’re a drug maker or animal caretaker, these approvals and sponsor changes could impact what medicines are available and when.
2026-13534 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
The FDA is asking for public feedback on how it collects information for formal hearings and administrative rules. This affects businesses and people who interact with the FDA, with no new costs but a chance to improve paperwork processes. Comments are due by August 5, 2026, so don’t miss your chance to weigh in!
2026-13616 — Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
The FDA is officially pulling the plug on 34 drug approvals because the companies stopped selling these medicines. This change kicks in on August 5, 2026, and it mainly affects drug makers like Endo Operations and Pfizer. No money penalties here—just a clean break, but companies can ask to reapply if they want to bring the drugs back.
Previous / Next Documents
Previous: 2025-18452 — Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish Certain Market Data Products
Cboe BZX Exchange is launching new market data products to give traders better info on complex options orders. This change affects anyone using BZX’s trading data and starts right away, with some new fees for accessing these data feeds. It’s a smart move to keep traders in the know and the market running smoothly.
Next: 2025-18456 — Notice of Determinations; Additional Culturally Significant Object Being Imported for Exhibition-Determinations: “Painted Worlds: Color and Culture in Mesoamerican Art” Exhibition
A new culturally important Mesoamerican art piece is joining the “Painted Worlds: Color and Culture in Mesoamerican Art” exhibition at the Nelson-Atkins Museum in Kansas City. This means visitors get to see even more amazing art, and the display is officially recognized as valuable for the nation. The object will be shown temporarily, with no extra costs to the public.