Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 91758 [2024-27090]
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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Vial, Was Not Withdrawn From Sale for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.
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withdrawn from sale for reasons of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the listed drug was withdrawn from sale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).
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:39 Nov 19, 2024
Jkt 265001
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
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
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.
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:
SUMMARY:
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
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[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.
-----------------------------------------------------------------------
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
