FDA Pulls Plug on Eight Unused Generic Drugs
Published Date: 3/14/2025
Notice
Summary
The FDA is officially pulling the plug on eight drug approvals because the companies stopped selling these medicines. This change kicks in on April 14, 2025, but companies can apply again if they want. Patients and pharmacies using these drugs should check for alternatives soon to avoid any hiccups.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Eight drug approvals withdrawn April 14, 2025
The FDA is withdrawing approval of eight abbreviated new drug applications as of April 14, 2025. The affected products are: ACETIC ACID 2% in aqueous aluminum acetate solution/drop; ERYTHROCIN STEARATE (erythromycin stearate) tablets (EQ 125 mg, EQ 250 mg, EQ 500 mg base); Levobunolol HCl solution/drop 0.25%; Cromolyn (cromolyn sodium) solution/drop 4%; Carteolol HCl solution/drop 1%; Amantadine HCl syrup 50 mg/5 mL; Metoprolol Tartrate injectable 1 mg/mL; and Azelastine HCl metered spray 0.2055 mg/spray. Patients and pharmacies using these specific products should check for alternatives because, after April 14, 2025, introduction into interstate commerce of these products without an approved application would violate federal law.
Existing inventory 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 inventories are depleted, until the products reach their expiration dates, or until they otherwise become violative—whichever occurs first. Pharmacies and other holders of on-hand stock can continue dispensing those lots for the short term under those limits.
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