FDA Yanks 15 Teva Generic Approvals for Dormant Drugs
Published Date: 5/7/2026
Notice
Summary
The FDA is officially pulling the plug on 15 generic drug approvals from Teva Pharmaceuticals and its related companies because these drugs aren’t being sold anymore. This change kicks in on June 8, 2026, and it won’t cost anyone money or cause shortages since the drugs are off the market. If Teva wants, they can ask to sell these drugs again later without any trouble.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
FDA withdraws 15 generic approvals
The FDA is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, including Teva Pharmaceuticals USA and related companies, effective June 8, 2026. The listed applicants requested withdrawal and waived their opportunity for a hearing. The withdrawal is without prejudice to refiling, so applicants may submit new applications later.
Existing stock can still be dispensed
If any of the listed drug products are in inventory on June 8, 2026, they may continue to be dispensed until inventories are depleted, the products reach their expiration dates, or they otherwise become violative. After those conditions occur, the products may not be introduced into interstate commerce without an approved application.
FDA says no cost or shortage expected
The FDA states the withdrawals apply to drug products that are no longer marketed and that the change takes effect on June 8, 2026. Because these products are off the market, the action is described as not causing costs to consumers or drug shortages.
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