[Federal Register Volume 90, Number 103 (Friday, May 30, 2025)]
[Notices]
[Pages 23060-23061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09779]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0184]
Determination That ACTIGALL (Ursodiol) Capsule, 150 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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 ACTIGALL (ursodiol) capsule, 150 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for ursodiol capsule, 150 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Madeleine Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 240-
863-8976, [email protected].
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
[[Page 23061]]
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FDA determines that the listed drug was withdrawn from sale for reasons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
(21 CFR 314.161). FDA may not approve an ANDA that does not refer to a
listed drug.
ACTIGALL (ursodiol) capsule, 150 mg, is the subject of NDA 019594,
held by Teva Branded Pharmaceutical Products R&D, Inc., and initially
approved on December 31, 1987. ACTIGALL is indicated for patients with
radiolucent, noncalcified gallbladder stones less than 20 millimeters
in greatest diameter in whom elective cholecystectomy would be
undertaken except for the presence of increased surgical risk due to
systemic disease, advanced age, or idiosyncratic reaction to general
anesthesia or for those patients who refuse surgery, and for the
prevention of gallstone formation in obese patients experiencing rapid
weight loss.
ACTIGALL (ursodiol) capsule, 150 mg, is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Pharmobedient Consulting, LLC submitted a citizen petition dated
January 14, 2025 (Docket No. FDA-2025-P-0184), under 21 CFR 10.30,
requesting that the Agency determine whether ACTIGALL (ursodiol)
capsule, 150 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 ACTIGALL (ursodiol) capsule, 150 mg, 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
ACTIGALL (ursodiol) capsule, 150 mg, 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 ACTIGALL (ursodiol)
capsule, 150 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. 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.
Dated: May 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09779 Filed 5-29-25; 8:45 am]
BILLING CODE 4164-01-P