FDA Greenlights Generics for Worm-Killing Biltricide Tablets
Published Date: 4/13/2026
Notice
Summary
The FDA has decided that BILTRICIDE (praziquantel) 600 mg tablets weren’t taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions, helping patients access affordable treatment without delays. No changes in safety rules or extra costs are expected, so everyone can breathe easy and keep treating their conditions smoothly.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Generics Can Continue Seeking Approval
The FDA decided that BILTRICIDE (praziquantel) 600 mg tablets were not withdrawn from sale for safety or effectiveness. Because of that decision (published April 13, 2026), FDA will not begin procedures to withdraw approval of ANDAs that refer to this drug, and ANDAs referencing this product may be approved if they meet legal and regulatory requirements.
Potential Labeling Update for ANDA Applicants
The FDA said that if it determines the drug's labeling should be revised to meet current standards, it will tell ANDA applicants to submit updated labeling. This means companies seeking approval may need to prepare and submit revised labels if FDA advises them to do so.
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