Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27135-27136 [2019-12308]
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
khammond on DSKBBV9HB2PROD with NOTICES
designated susceptible bacteria.
Subsequent to the NDA approvals, the
USPTO received patent term restoration
applications for BAXDELA (U.S. Patent
Nos. 7,728,143 and 8,252,813) from
Melinta Therapeutics, Inc., and the
USPTO requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
February 2, 2018, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approvals of
BAXDELA TABLETS and BAXDELA IV
INJECTION represent the first permitted
commercial marketing or use of the
products. Thereafter, the USPTO
requested that FDA determine the
products’ regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
BAXDELA TABLETS is 5,813 days. Of
this time, 5,569 days occurred during
the testing phase of the regulatory
review period, while 244 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
NDA 208610:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: July 22, 2001.
Melinta Therapeutics, Inc., claims that
July 27, 2001, is the date the
investigational new drug application
(IND) became effective. However, FDA
records indicate that the IND effective
date was July 22, 2001, which was 30
days after FDA receipt of the first IND.
2. The date new drug application
208610 was initially submitted with
respect to the human drug product
under section 505 of the FD&C Act:
October 19, 2016. FDA has verified the
applicant’s claim that the new drug
application (NDA) for BAXDELA (NDA
208610) was submitted on October 19,
2016.
3. The date the application was
approved: June 19, 2017. FDA has
verified the applicant’s claim that NDA
208610 was approved on June 19, 2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,307 or 1,001 days
of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
VerDate Sep<11>2014
17:36 Jun 10, 2019
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submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12299 Filed 6–10–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–4812]
Determination That NIZORAL
(Ketoconazole) Topical Cream, 2%,
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, Agency, or we)
has determined that NIZORAL
(ketoconazole) topical cream, 2%, was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
SUMMARY:
PO 00000
Frm 00061
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27135
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363.
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NIZORAL (ketoconazole) topical
cream, 2%, is the subject of NDA
019084, previously held by Johnson &
Johnson Pharmaceutical Research and
Development, LLC and initially
approved on December 31, 1985.
NIZORAL is indicated for the topical
treatment of tinea corporis, tinea cruris,
and tinea pedis caused by Trichophyton
rubrum, T. mentagrophytes, and
Epidermophyton floccosum; of tinea
(pityriasis) versicolor caused by
Malassezia furfur (Pityrosporum
orbiculare); of cutaneous candidiasis
caused by Candida spp.; and of
seborrheic dermatitis.
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khammond on DSKBBV9HB2PROD with NOTICES
27136
Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
In a letter dated August 25, 2004,
Johnson & Johnson Pharmaceutical
Research and Development, LLC
requested withdrawal of NDA 019084
for NIZORAL (ketoconazole) topical
cream, 2%. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA
announced that it was withdrawing
approval of NDA 019084, effective
December 7, 2007.
Arent Fox LLP submitted a citizen
petition dated December 19, 2018
(Docket No. FDA–2018–P–4812), under
21 CFR 10.30, requesting that the
Agency determine whether NIZORAL
(ketoconazole) topical cream, 2%, 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 NIZORAL (ketoconazole)
topical cream, 2%, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
NIZORAL (ketoconazole) topical cream,
2%, was withdrawn for reasons of safety
or effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of NIZORAL
(ketoconazole) topical cream, 2%, 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 NIZORAL
(ketoconazole) topical cream, 2%, 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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12308 Filed 6–10–19; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2039]
Development of Best Practices in
Physiologically Based
Pharmacokinetic Modeling To Support
Clinical Pharmacology Regulatory
Decision-Making; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER), in
collaboration with the Center for
Biologics Evaluation and Research
(CBER), is announcing a public
workshop entitled ‘‘Development of
Best Practices in Physiologically Based
Pharmacokinetic Modeling to Support
Clinical Pharmacology Regulatory
Decision-Making.’’ The purpose of this
public workshop is to discuss best
practices and evidentiary criteria in the
use of physiologically based
pharmacokinetic (PBPK) modeling
approaches to support regulatory
decision-making; share experiences and
cases where applying PBPK modeling
and simulation highlight the
opportunities and limitations of this
approach; obtain input from
stakeholders on when, where, how, and
with what limitations PBPK modeling
and simulation may be applied in
regulatory decision-making; and discuss
the knowledge gaps and research
needed to advance PBPK modeling
sciences in drug development to
support regulatory decisions. This
public workshop is also being
conducted to satisfy one of FDA’s
performance goals included in the sixth
reauthorization of the Prescription Drug
User Fee Amendments (PDUFA VI), part
of the FDA Reauthorization Act of 2017
(FDARA), to hold a series of workshops
related to model-informed drug
development (MIDD).
DATES: The public workshop will be
held on November 18, 2019, from 8 a.m.
to 5 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503, B and C), Silver Spring, MD
20993–0002. Entrance for public
workshop participants (non-FDA
employees) is through Building 1 where
routine security procedures will be
SUMMARY:
PO 00000
Frm 00062
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performed. For parking and security
information, please refer to: https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Lauren Milligan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3159,
Silver Spring, MD 20993–0002, 240–
402–6421, email: Lauren.Brum@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA, and in accordance
with section I, part J of the PDUFA VI
Performance Goals, FDA agreed to
convene a series of workshops to
identify best practices for MIDD (https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf at 27). FDA is
conducting this workshop as part of the
MIDD workshop series.
PBPK modeling is a drug
development tool that mathematically
integrates physiological,
physicochemical, and drug-dependent
preclinical and clinical information to
predict an investigational drug’s
absorption, distribution, metabolism,
excretion, and pharmacokinetics (PK).
Over the past several decades, there has
been extensive research using PBPK
modeling and simulation to address a
wide range of clinical questions, such as
exploring the effects of extrinsic factors
(e.g., concomitant medications, food
intake) and intrinsic factors (e.g., age,
organ dysfunction, disease status,
genetics) on drug exposures.
FDA notes that PBPK modeling and
simulation approaches are extensively
used in regulatory submissions to
predict the potential for drug-drug
interactions and to support dosing
recommendations for certain drugs
when they are co-administered with
metabolic enzyme modulators.
However, challenges and knowledge
gaps prevent PBPK modeling from being
routinely used for specific regulatory
decisions. Given the current limitations
of the approach, it is important that the
scientific community explore when,
where, and how PBPK modeling and
simulation may be applied in regulatory
decision-making.
II. Objectives
The objectives of the workshop are to:
1. Discuss ‘‘best practices’’ in integrating in
vitro and in vivo data to develop PBPK
models and developing evidentiary criteria
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27135-27136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12308]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-4812]
Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, 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, Agency, or we) has
determined that NIZORAL (ketoconazole) topical cream, 2%, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.
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.
NIZORAL (ketoconazole) topical cream, 2%, is the subject of NDA
019084, previously held by Johnson & Johnson Pharmaceutical Research
and Development, LLC and initially approved on December 31, 1985.
NIZORAL is indicated for the topical treatment of tinea corporis, tinea
cruris, and tinea pedis caused by Trichophyton rubrum, T.
mentagrophytes, and Epidermophyton floccosum; of tinea (pityriasis)
versicolor caused by Malassezia furfur (Pityrosporum orbiculare); of
cutaneous candidiasis caused by Candida spp.; and of seborrheic
dermatitis.
[[Page 27136]]
In a letter dated August 25, 2004, Johnson & Johnson Pharmaceutical
Research and Development, LLC requested withdrawal of NDA 019084 for
NIZORAL (ketoconazole) topical cream, 2%. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA announced that it was withdrawing
approval of NDA 019084, effective December 7, 2007.
Arent Fox LLP submitted a citizen petition dated December 19, 2018
(Docket No. FDA-2018-P-4812), under 21 CFR 10.30, requesting that the
Agency determine whether NIZORAL (ketoconazole) topical cream, 2%, 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 NIZORAL (ketoconazole) topical cream, 2%, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that NIZORAL
(ketoconazole) topical cream, 2%, was withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NIZORAL (ketoconazole) topical cream, 2%,
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 NIZORAL
(ketoconazole) topical cream, 2%, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12308 Filed 6-10-19; 8:45 am]
BILLING CODE 4164-01-P
