Determination That NEO TECT KIT (Kit for the Preparation of Technetium TC-99m Depreotide Injection) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 12565 [2020-04319]
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Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
Dated: February 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04361 Filed 3–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–3082]
Determination That NEO TECT KIT (Kit
for the Preparation of Technetium TC–
99m Depreotide Injection) 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Withdrawn From Sale for Reasons of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 NEO TECT KIT (Kit for
the Preparation of Technetium Tc 99m
Depreotide Injection) was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) that refer to the
product, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Michelle T. Weiner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 240–
402–0374, Michelle.Weiner@
fda.hhs.gov.
SUMMARY:
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
approved previously. 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
lotter on DSKBCFDHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:19 Mar 02, 2020
Jkt 250001
‘‘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 it 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.
NEO TECT KIT (Kit for the
Preparation of Technetium Tc 99m
Depreotide Injection) is the subject of
NDA 021012, currently held by CIS Bio
International SA, approved on August 3,
1999. NEO TECT KIT is a scintigraphic
imaging agent that identifies
somatostatin receptor-bearing
pulmonary masses in patients
presenting with pulmonary lesions on
computed tomography and/or chest x
ray who have known malignancy or
who are highly suspect for malignancy.
NEO TECT KIT (Kit for the
Preparation of Technetium Tc 99m
Depreotide Injection) is listed as
Discontinued in the Orange Book.
Andarix Pharmaceuticals, Inc.
submitted a citizen petition dated June
25, 2019 (Docket No. FDA–2019–P–
3082), under 21 CFR 10.30, requesting
that the Agency determine whether NEO
TECT KIT (Kit for the Preparation of
Technetium Tc 99m Depreotide
Injection) was withdrawn from sale
voluntarily for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records with
respect to NEO TECT KIT and based on
the information we have at this time,
FDA has determined under § 314.161
that NEO TECT KIT (Kit for the
Preparation of Technetium Tc 99m
Depreotide Injection) was not
withdrawn from sale for reasons of
safety or effectiveness. FDA carefully
reviewed its files for records concerning
the withdrawal of NEO TECT KIT (Kit
for the Preparation of Technetium Tc
99m Depreotide Injection) from sale. In
addition, the Agency independently
evaluated relevant literature and data
for possible post-marketing adverse
events. We have found no information
that would indicate that this drug
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
12565
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list NEO TECT KIT (Kit for
the Preparation of Technetium Tc 99m
Depreotide Injection) 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 NEO TECT KIT (Kit for the
Preparation of Technetium Tc 99m
Depreotide Injection) 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: February 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04319 Filed 3–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–E–2615 and FDA–
2018–E–2616]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ILUMYA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ILUMYA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by May 4, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
SUMMARY:
E:\FR\FM\03MRN1.SGM
03MRN1
]]>Agencies
[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Page 12565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-3082]
Determination That NEO TECT KIT (Kit for the Preparation of
Technetium TC-99m Depreotide Injection) 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 NEO TECT KIT (Kit for the Preparation of Technetium Tc
99m Depreotide Injection) was not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) that refer to the product, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Michelle T. Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-
402-0374, [email protected].
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 approved previously. 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 from sale,
but it 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.
NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m
Depreotide Injection) is the subject of NDA 021012, currently held by
CIS Bio International SA, approved on August 3, 1999. NEO TECT KIT is a
scintigraphic imaging agent that identifies somatostatin receptor-
bearing pulmonary masses in patients presenting with pulmonary lesions
on computed tomography and/or chest x ray who have known malignancy or
who are highly suspect for malignancy.
NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m
Depreotide Injection) is listed as Discontinued in the Orange Book.
Andarix Pharmaceuticals, Inc. submitted a citizen petition dated
June 25, 2019 (Docket No. FDA-2019-P-3082), under 21 CFR 10.30,
requesting that the Agency determine whether NEO TECT KIT (Kit for the
Preparation of Technetium Tc 99m Depreotide Injection) was withdrawn
from sale voluntarily for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
with respect to NEO TECT KIT and based on the information we have at
this time, FDA has determined under Sec. 314.161 that NEO TECT KIT
(Kit for the Preparation of Technetium Tc 99m Depreotide Injection) was
not withdrawn from sale for reasons of safety or effectiveness. FDA
carefully reviewed its files for records concerning the withdrawal of
NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide
Injection) from sale. In addition, the Agency independently evaluated
relevant literature and data for possible post-marketing 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 NEO TECT KIT (Kit for
the Preparation of Technetium Tc 99m Depreotide Injection) 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 NEO TECT KIT (Kit for
the Preparation of Technetium Tc 99m Depreotide Injection) 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: February 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04319 Filed 3-2-20; 8:45 am]
BILLING CODE 4164-01-P
