Opportunity
Federal Register #FDA-2025-P-5535
FDA Notice: Prednisolone Tablet, 5 mg, Regulatory Status Update
Buyer
Food and Drug Administration
Posted
June 26, 2026
Identifier
FDA-2025-P-5535
This notice from the Food and Drug Administration (FDA) provides an official determination regarding the regulatory status of prednisolone tablet, 5 mg. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Heather Drug Co. Inc. (holder of ANDA 080326 for prednisolone tablet, 5 mg) - Products/Services Referenced: - Prednisolone tablet, 5 mg (no specific part numbers or purchase quantities provided) - Notable Requirements and Details: - FDA confirms prednisolone tablet, 5 mg, was not withdrawn for safety or effectiveness reasons - The drug remains listed in the Discontinued Drug Product List section of the Orange Book - FDA will not withdraw approval of ANDAs referencing this product - Additional ANDAs may be approved if legal and regulatory requirements are met - Indicated for a broad range of medical conditions (endocrine, rheumatic, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, nervous system, and miscellaneous diseases) - No procurement, solicitation, or award action is being announced in this notice
Description
The Food and Drug Administration (FDA) has determined that prednisolone tablet, 5 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not withdraw approval of abbreviated new drug applications (ANDAs) referring to this drug, allowing continued approval as long as legal and regulatory requirements are met. The drug is indicated for various disorders including endocrine, rheumatic, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, nervous system, and miscellaneous diseases. The FDA will continue to list the drug in the Discontinued Drug Product List section of the Orange Book and may approve additional ANDAs for this product if requirements are met.