Federal Register #FDA-2025-P-2524

FDA Notice: BILTRICIDE (Praziquantel) Oral Tablet, 600 mg, Not Withdrawn for Safety or Effectiveness

This FDA notice addresses the regulatory status of BILTRICIDE (praziquantel) oral tablet, 600 mg: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Bayer Healthcare Pharmaceuticals, Inc. (original NDA holder) - Novitium Pharma LLC (citizen petition filer) - Product Details: - BILTRICIDE (praziquantel) oral tablet, 600 mg - Indicated for treatment of schistosomiasis and certain liver fluke infections - Remains listed in the Discontinued Drug Product List for reasons other than safety or effectiveness - Notable Requirements and Determinations: - FDA determined the product was not withdrawn for safety or effectiveness reasons - Generic drug applications (ANDAs) referencing this product may continue to be approved if they meet all requirements - Decision based on review of agency records, literature, and a citizen petition - No procurement or award is being made; this is a regulatory notice affecting future generic drug submissions

Description

The Food and Drug Administration (FDA) has determined that BILTRICIDE (praziquantel) oral tablet, 600 mg, was not withdrawn from sale for reasons of safety or effectiveness. This means the FDA will not initiate procedures to withdraw approval of abbreviated new drug applications (ANDAs) referring to this drug and will continue to approve ANDAs that meet legal and regulatory requirements. The determination followed a citizen petition and a review of relevant data and literature, finding no evidence of withdrawal due to safety or effectiveness concerns.

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