Notice2026-07059
Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 13, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Administration (FDA or Agency) has determined that BILTRICIDE (praziquantel) oral tablet, 600 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 91 Issue 70 (Monday, April 13, 2026)</title>
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[Federal Register Volume 91, Number 70 (Monday, April 13, 2026)]
[Notices]
[Page 18866]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07059]
[[Page 18866]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-2524]
Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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(mg), was not withdrawn from sale for reasons of safety or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.
FOR FURTHER INFORMATION CONTACT: 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,
<a href="/cdn-cgi/l/email-protection#6b381f0a081245200a050e2b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="43103722203a6d08222d26032527226d2b2b306d242c35">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
BILTRICIDE (praziquantel) oral tablet, 600 mg, is the subject of
NDA 018714, held by Bayer Heathcare Pharmaceuticals, Inc., and
initially approved on December 29, 1982. BILTRICIDE is indicated in
patients aged 1 year and older for the treatment of the following
infections:
<bullet> Schistosomiasis due to all species of schistosoma (for
example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma
mansoni, and Schistosoma hematobium), and
<bullet> Clonorchiasis and Opisthorchiasis due to the liver flukes,
Clonorchis sinensis/Opisthorchis viverrini (approval of this indication
was based on studies in which the two species were not differentiated).
In a letter dated February 8, 2024, Bayer Healthcare
Pharmaceuticals, Inc. notified FDA that BILTRICIDE (praziquantel) oral
tablet, 600 mg, was being discontinued, and FDA moved the drug product
to the ``Discontinued Drug Product List'' section of the Orange Book.
Novitium Pharma LLC submitted a citizen petition dated July 18,
2025 (Docket No. FDA-2025-P-2524), under 21 CFR 10.30, requesting that
the Agency determine whether BILTRICIDE (praziquantel) oral tablet, 600
mg, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that BILTRICIDE (praziquantel) oral tablet, 600 mg,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
BILTRICIDE (praziquantel) oral tablet, 600 mg, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of BILTRICIDE
(praziquantel) oral tablet, 600 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list BILTRICIDE
(praziquantel) oral tablet, 600 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. ANDAs that refer to
this drug product may be approved by the Agency as long as they meet
all other legal and regulatory requirements for the approval of ANDAs.
If FDA determines that labeling for this drug product should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07059 Filed 4-10-26; 8:45 am]
BILLING CODE 4164-01-P
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