Federal Register #FDA-2026-P-0749

FDA Regulatory Determination on Leucovorin Calcium Oral Solution, 60 mg Base/Vial

This FDA notice clarifies the regulatory status of Leucovorin Calcium oral solution, 60 mg base/vial: - Government buyer: Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and vendors mentioned: - Hospira Inc. (original NDA holder) - Apotex, Inc. (citizen petition submitter) - Product referenced: - Leucovorin Calcium oral solution, equivalent to 60 mg base per vial (NDA 008107) - Key details: - FDA determined the drug was not withdrawn for safety or effectiveness reasons - Enables approval of generic versions (ANDAs) if all requirements are met - Product remains listed as discontinued in the Orange Book for reasons other than safety or effectiveness - Notice is regulatory in nature, not a procurement or award - Notable requirement: - Clarifies pathway for generic drug applicants to seek FDA approval for this formulation

Description

The Food and Drug Administration (FDA) has determined that leucovorin calcium, oral solution, equivalent to 60 milligrams base per vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for this drug if all other legal and regulatory requirements are met. The drug is listed in the Discontinued Drug Product List section of the Orange Book, indicating it was discontinued for reasons other than safety or effectiveness. The FDA reviewed the citizen petition and agency records and found no evidence suggesting withdrawal for safety or effectiveness reasons.

View original listing