FDA Backtracks on Withdrawing Amantadine Syrup Approval
Published Date: 9/4/2025
Notice
Summary
The FDA fixed a mistake about pulling approval for eight generic drug applications. One company, CMP Pharma, asked to keep their approval for amantadine syrup, and the FDA agreed, so that drug’s approval stays active. This update clears up confusion and keeps things fair for the companies involved, effective April 14, 2025.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Keeps Amantadine Syrup Approval
The FDA corrected a March 14, 2025 notice and kept approval of ANDA 075819 for amantadine hydrochloride syrup, 50 mg/5 mL, held by CMP Pharma, Inc. The original notice said the approval would be withdrawn as of April 14, 2025, but CMP Pharma timely asked to retain approval, so the approval remains in effect.
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
2026-11739 — Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
The FDA is officially putting simple COVID-19 rapid test devices into a safer, easier-to-manage category called Class II. This change means these tests can get to patients faster and with fewer hoops to jump through, while still making sure they work well and stay safe. Starting June 11, 2026, companies making these tests will follow new rules that help speed up innovation without extra costs.
2026-11740 — Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
The FDA is officially putting the Spinal Muscular Atrophy (SMA) newborn screening test into class II, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps make the test safer and easier to get to babies who need it, starting June 11, 2026, with the classification effective since November 2022. Labs and device makers will benefit from clearer rules and faster access, helping catch SMA early without extra costs or delays.
2026-11760 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
The FDA is asking for approval to collect extra records from food businesses that handle certain high-risk foods. This helps track food sources quickly to keep everyone safe. Food companies should get ready to keep and share these new records, and comments on this plan are due by July 13, 2026.
2026-11762 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA is asking for approval to keep collecting info from seafood processors and importers to make sure fish products are safe using a system called HACCP. This affects anyone who processes or imports fish and requires them to keep records showing they’re following safety rules. Comments on this plan are open until July 13, 2026, and there’s no new cost, just a continuation of current paperwork.
2026-11589 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
The FDA has officially placed the combined acoustic and electrical external stimulation device for tinnitus relief into class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps patients get access to this innovative device faster and ensures it’s safe and effective. The new classification is effective June 10, 2026, with the rules applying retroactively from March 6, 2023.
2026-11578 — Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
The FDA just gave a thumbs-up to adding bemotrizinol as a new active ingredient in sunscreens, letting it be used up to 6% concentration. This means sunscreen makers can now include this ingredient, which is safe and effective, in their products. The change is official as of June 10, 2026, and could lead to better sun protection options without extra costs for consumers.
Previous / Next Documents
Previous: 2025-16904 — Notice of Agreements Filed
The Federal Maritime Commission announced updates to two shipping agreements involving companies like Crowley Caribbean Services and King Ocean. One change removes a member and updates contact info, while the other changes how expenses are shared. These updates take effect between late August and early October 2025, so affected companies should take note and act quickly if they want to comment.
Next: 2025-16906 — Notice of OFAC Sanctions Actions
The U.S. Treasury’s OFAC just took some folks off their special blacklist, meaning these people are no longer blocked or restricted. This change could open up new money moves and business chances for those involved. Keep an eye out because these updates happen right away and can impact who you can work with.