Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 58421 [2017-26693]
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
Perception: Evidence from a MetaAnalysis.’’ Journal of Communication,
58(2), 280–300, 2008.
19. DeLorme, D.E., J. Huh, and L.N. Reid.
‘‘Perceived Effects of Direct-ToConsumer (DTC) Prescription Drug
Advertising on Self and Others.’’ Journal
of Advertising, 35(3), 47–65, 2006.
20. Fisher, R.A. The Design of Experiments.
Edinburgh, United Kingdom: Oliver and
Boyd, 1937.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26704 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2659]
Determination That NOROXIN
(Norfloxacin) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for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 NOROXIN (norfloxacin)
tablets, 400 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for norfloxacin
tablets, 400 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
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
ethrower on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:03 Dec 11, 2017
Jkt 244001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NOROXIN (norfloxacin) tablets, 400
mg, is the subject of NDA 019384, held
by Merck & Company, Inc. (Merck), and
initially approved on October 31, 1986.
NOROXIN is indicated for the treatment
of adults with the following infections
caused by susceptible strains of certain
designated microorganisms:
Uncomplicated urinary tract infections
(including cystitis), uncomplicated
urethral and cervical gonorrhea, and
prostatitis.
In a letter dated October 13, 2015,
Merck notified FDA that NOROXIN
(norfloxacin) tablets, 400 mg, 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 October
4, 2016 (81 FR 68427), FDA announced
that it was withdrawing approval of
NDA 019384, effective November 3,
2016.
Jubilant Generics Ltd. submitted a
citizen petition dated April 27, 2017
(Docket No. FDA–2017–P–2659), under
21 CFR 10.30, requesting that the
Agency determine whether NOROXIN
(norfloxacin) tablets, 400 mg, 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 NOROXIN (norfloxacin)
tablets, 400 mg, was not withdrawn for
reasons of safety or effectiveness. The
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
58421
petitioner has identified no data or other
information suggesting that NOROXIN
(norfloxacin) tablets, 400 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of NOROXIN
(norfloxacin) tablets, 400 mg, 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 this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NOROXIN (norfloxacin)
tablets, 400 mg, 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 NOROXIN
(norfloxacin) tablets, 400 mg, 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,
the Agency will advise ANDA
applicants to submit such labeling.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26693 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–4079]
Product Name Placement, Size, and
Prominence in Promotional Labeling
and Advertisements; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Product
Name Placement, Size, and Prominence
in Promotional Labeling and
Advertisements.’’ The guidance clarifies
the requirements for product name
placement, size, prominence, and
frequency in promotional labeling and
advertisements for human prescription
drugs, including prescription biological
products, and for animal prescription
SUMMARY:
E:\FR\FM\12DEN1.SGM
12DEN1
]]>Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Page 58421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-2659]
Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams,
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 NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for norfloxacin tablets, 400 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.
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 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.
NOROXIN (norfloxacin) tablets, 400 mg, is the subject of NDA
019384, held by Merck & Company, Inc. (Merck), and initially approved
on October 31, 1986. NOROXIN is indicated for the treatment of adults
with the following infections caused by susceptible strains of certain
designated microorganisms: Uncomplicated urinary tract infections
(including cystitis), uncomplicated urethral and cervical gonorrhea,
and prostatitis.
In a letter dated October 13, 2015, Merck notified FDA that NOROXIN
(norfloxacin) tablets, 400 mg, 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 October 4, 2016 (81 FR
68427), FDA announced that it was withdrawing approval of NDA 019384,
effective November 3, 2016.
Jubilant Generics Ltd. submitted a citizen petition dated April 27,
2017 (Docket No. FDA-2017-P-2659), under 21 CFR 10.30, requesting that
the Agency determine whether NOROXIN (norfloxacin) tablets, 400 mg, 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 NOROXIN (norfloxacin) tablets, 400 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that NOROXIN
(norfloxacin) tablets, 400 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NOROXIN (norfloxacin) tablets, 400 mg,
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 this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NOROXIN (norfloxacin)
tablets, 400 mg, 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 NOROXIN (norfloxacin) tablets, 400 mg, 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, the Agency will advise ANDA applicants
to submit such labeling.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26693 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P
