83_FR_64369 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IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

Page Range64130-64131
FR Document2018-26975

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that IC-GREEN (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness.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 Issue 239 (Thursday, December 13, 2018) 
[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Withdrawn From Sale for Reasons of Safety or Effectiveness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.

-----------------------------------------------------------------------

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milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn 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

64130 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices RPG CROSS-SITE EVALUATION ANNUALIZED BURDEN ESTIMATES—Continued Number of Average Total number responses per burden hours Estimated total Total annual Data collection activity of respondents respondent per response burden hours burden hours (each year) (in hours) Partner survey ...................................................................... 135 .33 0.42 56.3 18.8 Enrollment, client and service data Semi-annual progress reports ............................................. 27 2 16.5 2,673 891 Case enrollment data ........................................................... 81 43 0.25 2,612.3 870.8 Case closure ........................................................................ 81 43 0.017 174.2 58.1 Case closure—prenatal ....................................................... 81 33 0.017 133.7 44.6 Service log entries ............................................................... 162 2,288 0.03 37,065 12,355 Outcome and impact data Administrative Data: Obtain access to administrative data ........................... 27 1 42.6 3,450.6 1150.2 Report administrative data ............................................ 27 2 144 23,328 7,776 Standardized instruments: Review and adopt reporting templates ......................... 27 .33 8 216 72 Data entry for standardized instruments ...................... 27 130 1.25 13,162.5 4,387.5 Review records and submit .......................................... 27 2 25 4,050 1,350 Data entry for comparison study sites (22 grantees) ... 22 130 1.25 10,725 3,575 Estimated Total Burden Hours ..................................... ........................ ........................ ........................ 97,827 32,609 Additional Information: Copies of the DEPARTMENT OF HEALTH AND Restoration Act of 1984 (Pub. L. 98–417) proposed collection may be obtained by HUMAN SERVICES (the 1984 amendments), which writing to the Administration for authorized the approval of duplicate Children and Families, Office of Food and Drug Administration versions of drug products under an Planning, Research and Evaluation, 330 [Docket No. FDA–2018–P–1734] ANDA procedure. ANDA applicants C Street SW, Washington, DC 20201. must, with certain exceptions, show that Attention Reports Clearance Officer. All Determination That IC–GREEN the drug for which they are seeking requests should be identified by the title (Indocyanine Green for Injection), 10 approval contains the same active of the information collection. Email Milligrams/Vial, 40 Milligrams/Vial, and ingredient in the same strength and address: infocollection@acf.hhs.gov. 50 Milligrams/Vial Were Not Withdrawn dosage form as the ‘‘listed drug,’’ which From Sale for Reasons of Safety or is a version of the drug that was OMB Comment: OMB is required to previously approved. ANDA applicants Effectiveness make a decision concerning the do not have to repeat the extensive collection of information between 30 AGENCY: Food and Drug Administration, clinical testing otherwise necessary to and 60 days after publication of this HHS. gain approval of a new drug application document in the Federal Register. ACTION: Notice. (NDA). Therefore, a comment is best assured of The 1984 amendments include what having its full effect if OMB receives it SUMMARY: The Food and Drug is now section 505(j)(7) of the Federal within 30 days of publication. Written Administration (FDA or Agency) has Food, Drug, and Cosmetic Act (21 U.S.C. comments and recommendations for the determined that IC–GREEN 355(j)(7)), which requires FDA to proposed information collection should (indocyanine green for injection), 10 publish a list of all approved drugs. be sent directly to the following: Office milligrams (mg)/vial, 40 mg/vial, and 50 FDA publishes this list as part of the of Management and Budget, Paperwork mg/vial, was not withdrawn from sale ‘‘Approved Drug Products with Reduction Project, Email: OIRA_ for reasons of safety or effectiveness. Therapeutic Equivalence Evaluations,’’ This determination will allow FDA to which is known generally as the SUBMISSION@OMB.EOP.GOV, Attn: approve abbreviated new drug ‘‘Orange Book.’’ Under FDA regulations, Desk Officer for the Administration for applications (ANDAs) for indocyanine drugs are removed from the list if the Children and Families. green for injection, 10 mg/vial, 40 mg/ Agency withdraws or suspends Robert Sargis, vial, and 50 mg/vial if all other legal and approval of the drug’s NDA or ANDA Reports Clearance Officer. regulatory requirements are met. for reasons of safety or effectiveness or [FR Doc. 2018–27041 Filed 12–12–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: if FDA determines that the listed drug BILLING CODE 4184–01–P Heather A. Dorsey, Center for Drug was withdrawn from sale for reasons of Evaluation and Research, Food and safety or effectiveness (21 CFR 314.162). amozie on DSK3GDR082PROD with NOTICES1 Drug Administration, 10903 New A person may petition the Agency to Hampshire Ave., Bldg. 51, Rm. 6219, determine, or the Agency may Silver Spring, MD 20993–0002, 301– determine on its own initiative, whether 796–3601. a listed drug was withdrawn from sale SUPPLEMENTARY INFORMATION: In 1984, for reasons of safety or effectiveness. Congress enacted the Drug Price This determination may be made at any Competition and Patent Term time after the drug has been withdrawn VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1

Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices 64131 from sale, but must be made prior to § 314.161 that IC–GREEN (indocyanine DEPARTMENT OF HEALTH AND approving an ANDA that refers to the green for injection), 10 mg/vial, 40 mg/ HUMAN SERVICES listed drug (§ 314.161 (21 CFR 314.161)). vial, and 50 mg/vial, was not withdrawn FDA may not approve an ANDA that for reasons of safety or effectiveness. Food and Drug Administration does not refer to a listed drug. The petitioner has identified no data or IC–GREEN (indocyanine green for other information suggesting that IC– [Docket No. FDA–2018–N–4416] injection), 10 mg/vial, 25 mg/vial, 40 GREEN (indocyanine green for mg/vial, and 50 mg/vial, is the subject injection), 10 mg/vial, 40 mg/vial, and Allied Pharma, Inc., et al.; Withdrawal of NDA 011525, held by Akorn, Inc. IC– 50 mg/vial, was withdrawn for reasons of Approval of Nine Abbreviated New GREEN (indocyanine green for of safety or effectiveness. We have Drug Applications injection), 25 mg/vial and 50 mg/vial, carefully reviewed our files for records became conditionally effective on concerning the withdrawal of IC– AGENCY: Food and Drug Administration, February 2, 1959. IC–GREEN GREEN (indocyanine green for HHS. (indocyanine green for injection), 10 injection), 10 mg/vial, 40 mg/vial, and ACTION: Notice. mg/vial and 40 mg/vial, became 50 mg/vial from sale. We have also conditionally effective on March 20, independently evaluated relevant SUMMARY: The Food and Drug 1967. NDA 011525 was included in the literature and data for possible Administration (FDA or Agency) is Drug Efficacy Study Implementation postmarketing adverse events. We have withdrawing approval of nine review, (35 FR 12231 (July 30, 1970); 42 reviewed the available evidence and abbreviated new drug applications FR 31495 (June 21, 1977)) and the determined that these drug products (ANDAs) from multiple applicants. The application was approved on August 2, were not withdrawn from sale for applicants notified the Agency in 1989. IC–GREEN (indocyanine green for reasons of safety or effectiveness. writing that the drug products were no injection) is indicated for determining Accordingly, the Agency will longer marketed and requested that the cardiac output, hepatic function, and continue to list IC–GREEN (indocyanine approval of the applications be liver blood flow, and for ophthalmic green for injection), 10 mg/vial, 40 mg/ withdrawn. angiography. vial, and 50 mg/vial, in the IC–GREEN (indocyanine green for ‘‘Discontinued Drug Product List’’ DATES: Approval is withdrawn as of injection), 10 mg/vial, 40 mg/vial, and section of the Orange Book. The January 14, 2019. 50 mg/vial, is currently listed in the ‘‘Discontinued Drug Product List’’ FOR FURTHER INFORMATION CONTACT: ‘‘Discontinued Drug Product List’’ delineates, among other items, drug Trang Tran, Center for Drug Evaluation section of the Orange Book. products that have been discontinued and Research, Food and Drug Foley & Lardner LLP submitted a from marketing for reasons other than Administration, 10903 New Hampshire citizen petition dated May 3, 2018 safety or effectiveness. ANDAs that refer Ave., Bldg. 75, Rm. 1671, Silver Spring, (Docket No. FDA–2018–P–1734), under to IC–GREEN (indocyanine green for MD 20993–0002, 240–402–7945, 21 CFR 10.30, requesting that the injection), 10 mg/vial, 40 mg/vial, and Trang.Tran@fda.hhs.gov. Agency determine whether IC–GREEN 50 mg/vial, may be approved by the (indocyanine green for injection), 10 Agency as long as they meet all other SUPPLEMENTARY INFORMATION: The mg/vial, 40 mg/vial, and 50 mg/vial, legal and regulatory requirements for applicants listed in the table have was withdrawn from sale for reasons of the approval of ANDAs. If FDA informed FDA that these drug products safety or effectiveness. In 1987, IC– determines that labeling for this drug are no longer marketed and have GREEN (indocyanine green for product should be revised to meet requested that FDA withdraw approval injection), 10 mg/vial and 40 mg/vial current standards, the Agency will of the applications under the process were discontinued from marketing. In advise ANDA applicants to submit such described in § 314.150(c) (21 CFR 1996, Akorn, Inc. discontinued labeling. 314.150(c)). The applicants have also, marketing IC–GREEN (indocyanine by their requests, waived their Dated: December 10, 2018. opportunity for a hearing. Withdrawal green for injection), 50mg/vial. After considering the citizen petition Leslie Kux, of approval of an application or and reviewing Agency records, and Associate Commissioner for Policy. abbreviated application under based on the information we have at this [FR Doc. 2018–26975 Filed 12–12–18; 8:45 am] § 314.150(c) is without prejudice to time, FDA has determined under BILLING CODE 4164–01–P refiling. Application No. Drug Applicant ANDA 073079 ................................. Loperamide Hydrochloride (HCl) Oral Solution, 1 Allied Pharma, Inc., 20 Corrielle St., Fords, NJ milligram (mg)/5 milliliters. 08863. ANDA 076741 ................................. Ibuprofen Tablets USP, 100 mg ................................ LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 11788. ANDA 080210 ................................. Lidocaine Ointment, 5% ............................................ Belmora, LLC, 2231 Crystal Dr., #1000, Arlington, VA 22202. ANDA 085497 ................................. Phendimetrazine Tartrate Tablets, 35 mg ................. Virtus Pharmaceuticals, LLC, 2050 Cabot Blvd. West, 2nd Floor, Langhorne, PA 19047. ANDA 085695 ................................. Phendimetrazine Tartrate Capsules, 35 mg ............. Do. ANDA 086365 ................................. Phendimetrazine Tartrate Tablets, 35 mg ................. Do. amozie on DSK3GDR082PROD with NOTICES1 ANDA 086399 ................................. Theolair (theophylline) Tablets, 125 mg and 250 mg Medicis Pharmaceutical Corp., c/o Valeant Pharma- ceuticals North America, LLC, 400 Somerset Cor- porate Blvd., Bridgewater, NJ 08807. ANDA 087378 ................................. Phendimetrazine Tartrate Extended-Release Cap- Virtus Pharmaceuticals, LLC. sules, 105 mg. ANDA 202030 ................................. Bromfenac Sodium Ophthalmic Solution, Equivalent Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., to 0.09% Acid. Suite 205, Berwyn, PA 19312. VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1


Document Created: 2018-12-13 01:16:01
Document Modified: 2018-12-13 01:16:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactHeather 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.
FR Citation83 FR 64130 
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