Old Drug Gets Green Light for Generic Copycats
Published Date: 5/8/2026
Notice
Summary
The FDA has decided that leucovorin calcium oral solution (60 mg per vial) wasn’t taken off the market because it was unsafe or ineffective. This means generic drug makers can now apply to sell their versions, speeding up access for patients. No extra safety worries or delays—just more options coming soon!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generic Access for Leucovorin 60 mg
The FDA determined that leucovorin calcium oral solution equivalent to 60 milligrams base per vial was not withdrawn from sale for reasons of safety or effectiveness. Because of this, abbreviated new drug applications (ANDAs) that refer to this listed drug may be approved if they meet all other legal and regulatory requirements, which can allow generic manufacturers to market equivalent products and increase patient access.
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