FDA Confirms Dexamethasone Safe for Ongoing Generic Approvals
Published Date: 5/6/2026
Notice
Summary
The FDA has decided that Dexamethasone Elixir, 0.5 mg/5 mL, wasn’t taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions, keeping options open for patients and pharmacies. No changes in costs or availability are expected, so everyone can breathe easy!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
FDA Finds Dexamethasone Not Withdrawn
On May 6, 2026, FDA determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. FDA reviewed the files and relevant postmarketing data and found no information indicating the product was withdrawn for safety or effectiveness.
Generic Approvals Can Continue
Because FDA concluded the listed DEXAMETHASONE elixir was not withdrawn for safety or effectiveness, FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this product and may continue to approve new ANDAs that refer to it so long as they meet legal and regulatory requirements. The listed product is ANDA 088254, originally approved July 27, 1983.
Possible Labeling Updates for ANDAs
FDA stated that if it determines labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. The product was reported discontinued by Wockhardt Bio AG in a November 16, 2021 letter and a citizen petition was submitted February 4, 2026.
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