Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Published Date: 6/26/2026
Notice
Summary
The FDA has decided that the 5 mg prednisolone tablet 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 of this medicine, as long as they follow the rules. Patients and pharmacies can expect continued access to affordable generics without any interruptions or extra costs.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
ANDA Approvals for Prednisolone 5 mg Allowed
The FDA will not begin procedures to withdraw approval of approved abbreviated new drug applications (ANDAs) that refer to prednisolone tablet, 5 mg, and may continue to approve additional ANDAs that reference this product if they meet legal and regulatory requirements. The product remains listed in the Orange Book’s "Discontinued Drug Product List," and this determination follows a citizen petition filed October 21, 2025.
Generics Stay Available for Prednisolone 5 mg
The FDA has determined that prednisolone tablet, 5 mg, was not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, patients and pharmacies can expect continued access to affordable generic versions without interruptions or extra costs, and ANDAs that refer to this product may continue to be approved if they meet legal and regulatory requirements.
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