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IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 64130-64131 [2018-26975]
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64130
Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
RPG CROSS-SITE EVALUATION ANNUALIZED BURDEN ESTIMATES—Continued
Data collection activity
Total number
of respondents
Number of
responses per
respondent
(each year)
135
.33
Partner survey ......................................................................
Average
burden hours
per response
(in hours)
Estimated total
burden hours
Total annual
burden hours
0.42
56.3
18.8
2
43
43
33
2,288
16.5
0.25
0.017
0.017
0.03
2,673
2,612.3
174.2
133.7
37,065
891
870.8
58.1
44.6
12,355
27
27
1
2
42.6
144
3,450.6
23,328
1150.2
7,776
27
27
27
22
.33
130
2
130
8
1.25
25
1.25
216
13,162.5
4,050
10,725
72
4,387.5
1,350
3,575
........................
........................
........................
97,827
32,609
Enrollment, client and service data
Semi-annual progress reports .............................................
Case enrollment data ...........................................................
Case closure ........................................................................
Case closure—prenatal .......................................................
Service log entries ...............................................................
27
81
81
81
162
Outcome and impact data
Administrative Data:
Obtain access to administrative data ...........................
Report administrative data ............................................
Standardized instruments:
Review and adopt reporting templates .........................
Data entry for standardized instruments ......................
Review records and submit ..........................................
Data entry for comparison study sites (22 grantees) ...
Estimated Total Burden Hours .....................................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–27041 Filed 12–12–18; 8:45 am]
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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.
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
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
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 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
§ 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
64131
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4416]
Allied Pharma, Inc., et al.; Withdrawal
of Approval of Nine Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of nine
abbreviated new drug applications
(ANDAs) from multiple applicants. The
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Approval is withdrawn as of
January 14, 2019.
DATES:
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 073079 .................................
ANDA 076741 .................................
Loperamide Hydrochloride (HCl) Oral Solution, 1
milligram (mg)/5 milliliters.
Ibuprofen Tablets USP, 100 mg ................................
ANDA 080210 .................................
Lidocaine Ointment, 5% ............................................
ANDA 085497 .................................
Phendimetrazine Tartrate Tablets, 35 mg .................
ANDA 085695 .................................
ANDA 086365 .................................
ANDA 086399 .................................
Phendimetrazine Tartrate Capsules, 35 mg .............
Phendimetrazine Tartrate Tablets, 35 mg .................
Theolair (theophylline) Tablets, 125 mg and 250 mg
ANDA 087378 .................................
Phendimetrazine Tartrate Extended-Release Capsules, 105 mg.
Bromfenac Sodium Ophthalmic Solution, Equivalent
to 0.09% Acid.
Allied Pharma, Inc., 20 Corrielle St., Fords, NJ
08863.
LNK International, Inc., 145 Ricefield Ln.,
Hauppauge, NY 11788.
Belmora, LLC, 2231 Crystal Dr., #1000, Arlington,
VA 22202.
Virtus Pharmaceuticals, LLC, 2050 Cabot Blvd.
West, 2nd Floor, Langhorne, PA 19047.
Do.
Do.
Medicis Pharmaceutical Corp., c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Virtus Pharmaceuticals, LLC.
ANDA 202030 .................................
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Amring Pharmaceuticals, Inc., 1235 Westlakes Dr.,
Suite 205, Berwyn, PA 19312.
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64130-64131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26975]
-----------------------------------------------------------------------
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
