91758 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 

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Vial, Was Not Withdrawn From Sale for 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. 

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withdrawn from sale for reasons of 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, 

Madeleine.Giaquinto@fda.hhs.gov. 

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the listed drug was withdrawn from sale 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 (§ 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 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3110] 

Miguel Angel Montalvo Villa: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) permanently 

debarring Miguel Angel Montalvo Villa 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. FDA 

bases this order on a finding that Mr. 

Montalvo Villa was convicted of 

multiple felonies under Federal law for 

conduct relating to the development or 

approval, including the process for 

development or approval, of any drug 

product. Mr. Montalvo Villa was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. As of September 19, 2024 (30 

days after receipt of the notice), Mr. 

Montalvo Villa has not responded. Mr. 

Montalvo Villa’s failure to respond and 

request a hearing constitutes a waiver of 

Mr. Montalvo Villa’s right to a hearing 

concerning this matter. 

DATES: This order is applicable 

November 20, 2024. 

ADDRESSES: Any application by Mr. 

Montalvo Villa for special termination 

of debarment under section 306(d)(4) of 

the FD&C Act (21 U.S.C. 335a(d)(4)) may 

be submitted at any time as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application does not include any 

confidential information that you or a 


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