FDA Confirms Safety of Deworming Drug for Generics
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. Doctors, patients, and drug companies can all breathe easy knowing this medicine stays available and trusted.
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Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Generic Approvals Can Continue
The FDA found that BILTRICIDE (praziquantel) 600 mg tablets were not withdrawn from sale for reasons of safety or effectiveness. Because of that finding (published April 13, 2026), the Agency will not begin procedures to withdraw approval of ANDAs that refer to this product and may continue approving generic versions that meet legal and regulatory requirements. The brand drug was initially approved December 29, 1982, and Bayer notified FDA of discontinuation on February 8, 2024.
Labeling Updates May Be Required for Generics
The FDA said that if it determines the drug's labeling should be updated to meet current standards, the Agency will advise ANDA applicants to submit revised labeling. This means companies seeking to market generic versions may need to change their labels to match any FDA-directed revisions.
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