United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-04-11 article Notices D09002ee1e072479d D09002ee1e072485d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) has determined that BILTRICIDE (praziquantel) oral tablet, 600 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. 91 FR 18866 https://www.govinfo.gov/app/details/FR-2026-04-13/2026-07059 2026-07059 fr13ap26-52 4164-01-P Docket No. FDA-2025-P-2524 https://www.govinfo.gov/app/details/FR-2026-04-13/2026-07059 https://www.govinfo.gov/content/pkg/FR-2026-04-13/html/2026-07059.htm https://www.govinfo.gov/content/pkg/FR-2026-04-13/pdf/2026-07059.pdf 1 p. 18866 18866 91 FR 18866 Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 91, Issue NOTICE 2026-07059 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2025-P-2524 4164-01-P 2026-07059 Notice.

The Food and Drug Administration (FDA or Agency) has determined that BILTRICIDE (praziquantel) oral tablet, 600 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, Stacy.Kane@fda.hhs.gov. Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness Biltricide (Praziquantel) Oral Tablet, 600 Milligrams, Stacy.Kane@fda.hhs.gov Vol. 91, no. 70 Office of the Federal Register, National Archives and Records Administration 2026-04-13 continuing daily deposited born digital 298 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-04-13 P0b002ee1e0704d2d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13ap26 https://www.govinfo.gov/app/details/FR-2026-04-13 https://www.govinfo.gov/content/pkg/FR-2026-04-13/pdf/FR-2026-04-13.pdf https://www.govinfo.gov/content/pkg/FR-2026-04-13/xml/FR-2026-04-13.xml fdlp 18767 19056 DGPO 2026-04-11 2026-04-11 FR-2026-04-13 machine generated eng FR FR-2026-04-13 91 70