Determination That SODIUM PERTECHNETATE TC-99M (Technetium Tc-99m Sodium Pertechnetate) Injection, Oral, 2 to 100 Millicuries per Milliliter and 10 to 60 Millicuries per Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 30851-30852 [2014-12351]
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Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–1516]
Determination That SODIUM
PERTECHNETATE TC–99M
(Technetium Tc-99m Sodium
Pertechnetate) Injection, Oral, 2 to 100
Millicuries per Milliliter and 10 to 60
Millicuries per Milliliter, 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Withdrawn From Sale for Reasons of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) has determined
that SODIUM PERTECHNETATE TC–
99M (technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
millicuries per milliliter (mCi/mL) and
10 to 60 mCi/mL, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
technetium Tc-99m sodium
pertechnetate, injection, oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6228, Silver Spring,
MD 20993–0002, 240–402–4191.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 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,’’
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:19 May 28, 2014
Jkt 232001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SODIUM PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL, is the subject of NDA 17–471,
held by GE Healthcare. SODIUM
PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 10 to 60
mCi/mL, is the subject of NDA 17–725,
held by Mallinckrodt Pharmaceuticals.
The most recent labeling indicates that
SODIUM PERTECHNETATE TC–99M is
used in adults as an agent for thyroid
imaging, salivary gland imaging, urinary
bladder imaging (direct isotopic
cystography) for the detection of
vesicoureteral reflux, and nasolacrimal
drainage system imaging
(dacryoscintigraphy). The most recent
labeling also indicates that SODIUM
PERTECHNETATE TC–99M is used in
children as an agent for thyroid imaging
and urinary bladder imaging (direct
isotopic cystography) for the detection
of vesicoureteral reflux.
In a letter dated April 15, 2004,
Amersham Health, the former holder of
NDA 17–471, notified FDA that
SODIUM PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
Federal Register of March 4, 2005 (70
FR 10651), FDA announced that it was
withdrawing approval of NDA 17–471.
In a letter dated October 23, 2006,
Mallinckrodt Pharmaceuticals, the
holder of NDA 17–725, notified FDA
that SODIUM PERTECHNETATE TC–
99M (technetium Tc-99m sodium
pertechnetate) Injection, Oral, 10 to 60
mCi/mL, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
30851
Federal Register of November 7, 2007
(72 FR 62858), FDA announced that it
was withdrawing approval of NDA 17–
725.
Spectron mrc, LLC, submitted a
citizen petition dated November 19,
2013 (Docket No. FDA–2013–P–1516),
under 21 CFR 10.30, requesting that the
Agency determine whether SODIUM
PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, were
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 SODIUM
PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that SODIUM
PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10–60 mCi/mL, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of SODIUM
PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, 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 these products
were withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list SODIUM
PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, 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 SODIUM PERTECHNETATE TC–99M
(technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, 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
E:\FR\FM\29MYN1.SGM
29MYN1
30852
Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Notices
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12351 Filed 5–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0622]
Draft Guidance for Industry on Best
Practices in Developing Proprietary
Names for Drugs; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Best Practices in
Developing Proprietary Names for
Drugs.’’ The draft guidance focuses on
the safety aspects in the development
and selection of proposed proprietary
names for all prescription and
nonprescription human drug products
and biological products. The draft
guidance describes naming design
practices to help avoid medication
errors and provides a qualitative
systematic framework for evaluating
proprietary names before submitting
them for FDA review. FDA is issuing
this draft guidance to help drug and
biologic product sponsors develop
proprietary names that do not cause or
contribute to medication errors or
otherwise contribute to the misbranding
of the drug.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 28, 2014.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:19 May 28, 2014
Jkt 232001
one self-addressed adhesive label to
assist that office in processing your
requests. The draft guidance may also be
obtained by calling CBER at 1–800–835–
4709 or 240–402–7800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kellie Taylor, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4418,
Silver Spring, MD 20993–0002, 301–
796–0157, or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Best Practices in Developing
Proprietary Names for Drugs.’’ FDA has
long recognized the importance of
proprietary name confusion as a
potential cause of medication errors,
and has addressed this issue repeatedly
in recent decades. Our primary focus
has been to develop and communicate
to sponsors a systematic, standardized,
and transparent approach to proprietary
name evaluation within the product
review and approval process. As part of
this initiative, FDA held public
meetings in June and December 2003 to
discuss the methods used for
proprietary name evaluation. In 2007,
FDA formally committed to certain
performance goals (under the
reauthorization of the Prescription Drug
User Fee Act (PDUFA IV) (Public Law
110–85), including implementing
measures to reduce medication errors
related to look-alike and sound-alike
proprietary names (PDUFA IV
performance goals). In 2008, FDA held
a public meeting to further discuss
testing and evaluating proprietary
names, and initiating a pilot project on
proprietary name review. The 2008
meeting focused on advances and
current limitations in the science of
proprietary name evaluation, FDA’s
recommendations for best practices in
the absence of a ‘‘gold standard,’’ and
details of the proposed pilot project.
The participating expert panel judged
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
all the evaluation methods proposed by
FDA to be complementary and of value
in the proprietary name testing process.
We are issuing this guidance in partial
fulfillment of the PDUFA IV
performance goals.
This draft guidance document, which
addresses minimizing risks through the
design of drug product naming, is the
last in a series of three guidance
documents that FDA is issuing to help
sponsors minimize the potential for
medication errors when designing and
developing products. The first draft
guidance, published in the Federal
Register on December 13, 2012 (77 FR
74196), focuses on minimizing risks
associated with the design of the drug
product and its container closure
system. The second draft guidance,
published in the Federal Register on
April 24, 2013 (78 FR 24211), focuses on
safety aspects of the container label and
carton labeling design.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on best practices for developing and
selecting proposed proprietary names to
minimize medication errors. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). Proprietary
name information submitted under 21
CFR part 314 has been approved under
OMB control number 0910–0001, and
proprietary name information submitted
under 21 CFR part 601 has been
E:\FR\FM\29MYN1.SGM
29MYN1
]]>Agencies
[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30851-30852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12351]
[[Page 30851]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-1516]
Determination That SODIUM PERTECHNETATE TC-99M (Technetium Tc-99m
Sodium Pertechnetate) Injection, Oral, 2 to 100 Millicuries per
Milliliter and 10 to 60 Millicuries per Milliliter, 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) has determined that
SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate)
Injection, Oral, 2 to 100 millicuries per milliliter (mCi/mL) and 10 to
60 mCi/mL, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for technetium Tc-99m sodium
pertechnetate, injection, oral, 2 to 100 mCi/mL and 10 to 60 mCi/mL, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 240-402-4191.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 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 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.
SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium
pertechnetate) Injection, Oral, 2 to 100 mCi/mL, is the subject of NDA
17-471, held by GE Healthcare. SODIUM PERTECHNETATE TC-99M (technetium
Tc-99m sodium pertechnetate) Injection, Oral, 10 to 60 mCi/mL, is the
subject of NDA 17-725, held by Mallinckrodt Pharmaceuticals. The most
recent labeling indicates that SODIUM PERTECHNETATE TC-99M is used in
adults as an agent for thyroid imaging, salivary gland imaging, urinary
bladder imaging (direct isotopic cystography) for the detection of
vesicoureteral reflux, and nasolacrimal drainage system imaging
(dacryoscintigraphy). The most recent labeling also indicates that
SODIUM PERTECHNETATE TC-99M is used in children as an agent for thyroid
imaging and urinary bladder imaging (direct isotopic cystography) for
the detection of vesicoureteral reflux.
In a letter dated April 15, 2004, Amersham Health, the former
holder of NDA 17-471, notified FDA that SODIUM PERTECHNETATE TC-99M
(technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 mCi/
mL, was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book. In the
Federal Register of March 4, 2005 (70 FR 10651), FDA announced that it
was withdrawing approval of NDA 17-471. In a letter dated October 23,
2006, Mallinckrodt Pharmaceuticals, the holder of NDA 17-725, notified
FDA that SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium
pertechnetate) Injection, Oral, 10 to 60 mCi/mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA announced that it was withdrawing
approval of NDA 17-725.
Spectron mrc, LLC, submitted a citizen petition dated November 19,
2013 (Docket No. FDA-2013-P-1516), under 21 CFR 10.30, requesting that
the Agency determine whether SODIUM PERTECHNETATE TC-99M (technetium
Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 mCi/mL and 10 to
60 mCi/mL, were 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 SODIUM PERTECHNETATE TC-99M (technetium Tc-99m
sodium pertechnetate) Injection, Oral, 2 to 100 mCi/mL and 10 to 60
mCi/mL, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate)
Injection, Oral, 2 to 100 mCi/mL and 10-60 mCi/mL, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of SODIUM PERTECHNETATE TC-
99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100
mCi/mL and 10 to 60 mCi/mL, 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
these products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list SODIUM PERTECHNETATE
TC-99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to
100 mCi/mL and 10 to 60 mCi/mL, 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 SODIUM PERTECHNETATE TC-99M
(technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 mCi/
mL and 10 to 60 mCi/mL, 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
[[Page 30852]]
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12351 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P
