[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Page 91758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27090]
[[Page 91758]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-3699]
Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/
Vial, Was Not Withdrawn From Sale for Reasons of Safety or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
determined that IC-GREEN (indocyanine green), 25 milligrams (mg)/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was not withdrawn from sale for reasons of safety or effectiveness.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 IC-GREEN (indocyanine green), 25 mg/vial, 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,
[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 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FDA determines that the listed drug was withdrawn from sale for reasons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.
IC-GREEN (indocyanine green), 25 mg/vial, is the subject of NDA
11525, held by Renew Pharmaceuticals and initially approved on February
9, 1959. IC-GREEN, 25 mg/vial, is indicated for determining cardiac
output, hepatic function, and liver blood flow.
IC-GREEN (indocyanine green), 25 mg/vial, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
Zydus Pharmaceuticals (USA), Inc. submitted a citizen petition
dated August 2, 2024 (Docket No. FDA-2024-P-3699), under 21 CFR 10.30,
requesting that the Agency determine whether IC-GREEN (indocyanine
green), 25 mg/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 IC-GREEN (indocyanine green), 25 mg/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
IC-GREEN (indocyanine green), 25 mg/vial, 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 IC-GREEN (indocyanine
green), 25 mg/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 or these drug products 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: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27090 Filed 11-19-24; 8:45 am]
BILLING CODE 4164-01-P