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[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Vial, Was Not Withdrawn From Sale for Reasons of Safety or 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was not withdrawn from sale for reasons of safety or effectiveness.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
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