83 FR 64130 - Determination That IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 239 (December 13, 2018)

The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness.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 indocyanine green for injection, 10 mg/vial, 40 mg/vial, and 50 mg/vial if all other legal and regulatory requirements are met.

[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64130-64131]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-1734]


Determination That IC-GREEN (Indocyanine Green for Injection), 10 
Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 for injection), 10 
milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn 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 
indocyanine green for injection, 10 mg/vial, 40 mg/vial, and 50 mg/vial 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
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

[[Page 64131]]

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 for injection), 10 mg/vial, 25 mg/vial, 
40 mg/vial, and 50 mg/vial, is the subject of NDA 011525, held by 
Akorn, Inc. IC-GREEN (indocyanine green for injection), 25 mg/vial and 
50 mg/vial, became conditionally effective on February 2, 1959. IC-
GREEN (indocyanine green for injection), 10 mg/vial and 40 mg/vial, 
became conditionally effective on March 20, 1967. NDA 011525 was 
included in the Drug Efficacy Study Implementation review, (35 FR 12231 
(July 30, 1970); 42 FR 31495 (June 21, 1977)) and the application was 
approved on August 2, 1989. IC-GREEN (indocyanine green for injection) 
is indicated for determining cardiac output, hepatic function, and 
liver blood flow, and for ophthalmic angiography.
    IC-GREEN (indocyanine green for injection), 10 mg/vial, 40 mg/vial, 
and 50 mg/vial, is currently listed in the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Foley & Lardner LLP submitted a citizen petition dated May 3, 2018 
(Docket No. FDA-2018-P-1734), under 21 CFR 10.30, requesting that the 
Agency determine whether IC-GREEN (indocyanine green for injection), 10 
mg/vial, 40 mg/vial, and 50 mg/vial, was withdrawn from sale for 
reasons of safety or effectiveness. In 1987, IC-GREEN (indocyanine 
green for injection), 10 mg/vial and 40 mg/vial were discontinued from 
marketing. In 1996, Akorn, Inc. discontinued marketing IC-GREEN 
(indocyanine green for injection), 50mg/vial.
    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 for 
injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn 
for reasons of safety or effectiveness. The petitioner has identified 
no data or other information suggesting that IC-GREEN (indocyanine 
green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of IC-GREEN 
(indocyanine green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/
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 these drug products 
were not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list IC-GREEN (indocyanine 
green for injection), 10 mg/vial, 40 mg/vial, and 50 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 IC-GREEN (indocyanine 
green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, 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: December 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26975 Filed 12-12-18; 8:45 am]
 BILLING CODE 4164-01-P