Notice2026-09199
Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
May 8, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that leucovorin calcium, oral solution, equivalent to (EQ) 60 milligrams (mg) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leucovorin calcium, oral solution, EQ 60 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 91 Issue 89 (Friday, May 8, 2026)</title>
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[Federal Register Volume 91, Number 89 (Friday, May 8, 2026)]
[Notices]
[Pages 25361-25362]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09199]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-P-0749]
Determination That Leucovorin Calcium, Oral Solution, Equivalent
to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of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
[[Page 25362]]
determined that leucovorin calcium, oral solution, equivalent to (EQ)
60 milligrams (mg) base/vial, was not withdrawn from sale for reasons
of safety or effectiveness. This determination will allow FDA to
approve abbreviated new drug applications (ANDAs) for leucovorin
calcium, oral solution, EQ 60 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Alexander Poonai, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3600, <a href="/cdn-cgi/l/email-protection#4b0a272e332a252f2e39651b2424252a220b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="db9ab7bea3bab5bfbea9f58bb4b4b5bab29bbdbfbaf5b3b3a8f5bcb4ad">[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.
Leucovorin calcium, oral solution, EQ 60 mg base/vial, is the
subject of NDA 008107, held by Hospira Inc., and initially approved on
January 30, 1987. Leucovorin calcium is indicated after high-dose
methotrexate therapy in osteosarcoma; to diminish the toxicity and
counteract the effects of impaired methotrexate elimination and of
inadvertent overdosages of folic acid antagonists; and for use in
combination with 5-fluorouracil to prolong survival in the palliative
treatment of patients with advanced colorectal cancer
Leucovorin calcium, oral solution, EQ 60 mg base/vial is currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Apotex, Inc. submitted a citizen petition dated January 23, 2026
(Docket No. FDA-2026-P-0749), under 21 CFR 10.30, requesting that the
Agency determine whether leucovorin calcium, oral solution, EQ 60 mg
base/vial, 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 leucovorin calcium, oral solution, EQ 60 mg
base/vial, was not withdrawn for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that this drug product was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of leucovorin calcium, oral solution, EQ 60
mg base/vial from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that this drug product
was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list leucovorin calcium,
oral solution, EQ 60 mg base/vial, 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. 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. 2026-09199 Filed 5-7-26; 8:45 am]
BILLING CODE 4164-01-P
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