FDA Yanks Plug on Four Forgotten Drugs No Longer for Sale
Published Date: 3/14/2025
Notice
Summary
The FDA is officially pulling the plug on four drug approvals from Bausch & Lomb, American Regent, and KubsTech because these medicines aren’t being sold anymore. This change kicks in on April 14, 2025, but companies can try again if they want. If you’re involved with these drugs, get ready for the update and plan accordingly!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Four ANDA approvals withdrawn April 14, 2025
The FDA is withdrawing approval of four abbreviated new drug applications (ANDAs) effective April 14, 2025: ANDA 040065 (Prednisolone Sodium Phosphate 0.11% drops) from Bausch & Lomb; ANDA 202031 (Gemcitabine injectable, EQ 200 mg and EQ 1 g vials) and ANDA 202562 (Dactinomycin injectable, 0.5 mg/vial) from American Regent; and ANDA 213390 (Vigabatrin solution, 500 mg/packet) for KubsTech/Propel Pharma. After April 14, 2025, introducing these listed products into interstate commerce without an approved new drug application or ANDA violates federal law (21 U.S.C. 355(a) and 331(d)).
Existing inventories may still be dispensed
Drug products listed in the withdrawal table that are in inventory on April 14, 2025 may continue to be dispensed until those inventories are depleted, reach their expiration dates, or otherwise become violative, whichever occurs first. This allows pharmacies and hospitals to use on-hand stock for patients for a limited time after the approval withdrawal.
Companies can refile; withdrawals are without prejudice
The applicants requested the withdrawals and waived their opportunity for a hearing; FDA states the withdrawal of approval under 21 CFR 314.150(c) is without prejudice to refiling. That means the listed applicants may refile ANDAs for these products in the future if they choose.
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