Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 56087-56088 [2018-24604]
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Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
Application No.
Drug
Applicant
ANDA 040747 ......................
Benzphetamine Hydrochloride (HCl) Tablets, 25 milligrams (mg) and 50 mg.
Gentamicin Sulfate Injection USP, Equivalent to (EQ)
10 mg base/milliliter (mL) and EQ 40 mg base/mL.
Isoflurane USP, 99.9% ....................................................
Tedor Pharma, Inc., 400 Highland Corporate Dr., Cumberland, RI 02864.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
Fresenius Kabi USA, LLC.
ANDA 062356 ......................
ANDA 074097 ......................
ANDA 076484 ......................
ANDA 080504 ......................
ANDA 083559 ......................
ANDA 084315 ......................
ANDA 084850 ......................
ANDA 086389 ......................
ANDA 087863 ......................
Ciprofloxacin Injection USP, 200 mg/20 mL and 400
mg/40 mL.
Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL;
2% and 0.02 mg/mL; 2%.
Lidocaine HCl Injection, 2%.
Mepivacaine HCl Injection, 3% .......................................
Dexamethasone Acetate Injectable Suspension USP,
EQ 8 mg base/mL.
Levonordefrin and Mepivacaine HCl Injection, 2%; 0.05
mg/mL.
Lidocaine HCl Viscous Oral Topical Solution USP, 2%
Choledyl SA (oxtriphylline) Extended-Release Tablets
USP, 400 mg.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of December 10,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on December 10,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24605 Filed 11–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–2506]
khammond on DSK30JT082PROD with NOTICES
56087
Determination That AXIRON
(Testosterone) Transdermal Metered
Solution, 30 Milligrams/1.5 Milliliter
Actuation, 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 AXIRON (testosterone)
SUMMARY:
VerDate Sep<11>2014
17:36 Nov 08, 2018
Jkt 247001
Belmora LLC, 2231 Crystal Dr., #1000, Arlington, VA
22202.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Belmora LLC.
International Medication Systems, Ltd., 1886 Santa
Anita Ave., South El Monte, CA 91733.
Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
transdermal metered solution, 30
milligrams (mg)/1.5 milliliter (mL)
actuation, 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 if 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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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.
AXIRON (testosterone) transdermal
metered solution, 30 mg/1.5 mL
actuation, is the subject of NDA 022504,
held by Eli Lilly and Company and
initially approved on November 23,
2010. AXIRON is indicated for
replacement therapy in males for
conditions associated with a deficiency
or absence of endogenous testosterone.
In a letter dated September 5, 2017,
Eli Lilly and Company requested
withdrawal of NDA 022504 for AXIRON
(testosterone). Eli Lilly and Company
later submitted a letter dated September
7, 2017 correcting a typographical error
in the September 5, 2017 letter. In the
Federal Register of June 21, 2018 (83 FR
28856), FDA announced that it was
withdrawing approval of NDA 022504,
effective July 23, 2018.
K&L Gates LLP submitted a citizen
petition received by FDA on June 27,
E:\FR\FM\09NON1.SGM
09NON1
56088
Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
khammond on DSK30JT082PROD with NOTICES
2018 (Docket No. FDA–2018–P–2506),
under 21 CFR 10.25 and 21 CFR 10.30,
requesting that the Agency determine
whether AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5
mL actuation, 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 AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5
mL actuation, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that AXIRON
(testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of AXIRON
(testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, 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 AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5
mL actuation, 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
that refer to 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: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24604 Filed 11–8–18; 8:45 am]
BILLING CODE 4164–01–P
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17:36 Nov 08, 2018
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Intent To Prepare an
Environmental Impact Statement and
Notice of Scoping Meeting
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In accordance with the
National Environmental Policy Act, the
National Institutes of Health (NIH) is
issuing this notice to advise the public
that an environmental impact statement
will be prepared for the Surgery,
Radiology and Lab Medicine Building
with associated Utility Vault and Patient
Parking Garage project located on the
National Institutes of Health, Bethesda
Campus, Bethesda, Maryland.
DATES: The Scoping Meeting is planned
for November 28, 2018, from 6 p.m.-9
p.m., with the formal presentation to
begin at 7 p.m. Scoping comments must
be postmarked no later than December
29, 2018, to ensure they are considered.
ADDRESSES: The Scoping Meeting will
be held at 6001 Executive Boulevard,
Rockville, MD 20852. All comments and
questions on the Scoping Meeting and
the Environmental Impact Statement
should be directed to Valerie
Nottingham, Deputy Director, Division
of Environmental Protection, Office of
Research Facilities, NIH, B13/2S11,
9000 Rockville Pike, Bethesda,
Maryland 20892, telephone 301–496–
7775; fax 301–480–0204; or email:
nihnepa@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Deputy Director,
Division of Environmental Protection,
Office of Research Facilities, NIH, B13/
2S11, 9000 Rockville Pike, Bethesda,
Maryland 20892, telephone 301–496–
7775; fax 301–480–0204; or email:
nihnepa@mail.nih.gov. For the purpose
of National Institutes of Health (NIH)
and its National Environmental Policy
Act (NEPA) procedures, the delegation
of authority to administer, interpret and
oversee the applicable environmental
laws, Executive Orders and regulations
for the NIH including the authority to
oversee and manage the NIH NEPA
program for assessing environmental
impacts and publish final decisions has
been given to the Director, Office of
Research Facilities Development and
Operation, Mr. Daniel G. Wheeland.
SUPPLEMENTARY INFORMATION: The NIH’s
mission is to seek fundamental
knowledge about the nature and
behavior of living systems and the
application of that knowledge to
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
enhance health, lengthen life, and
reduce illness and disability. In order to
fulfill and uphold this mission the
infrastructure of the NIH Bethesda
Campus must be able to support the
NIH’s biomedical research programs.
The proposed Surgery, Radiology and
Lab Medicine Building with associated
Utility Vault and Patient Parking Garage
project is to house General Radiology
and Imaging Services (RADIS), the
Department of Perioperative Medicine
(DPM), the Department of Laboratory
Medicine (DLM) and the relocated
functions for the National Cancer
Institute (NCI) in a state-of-the-art, safe,
functionally efficient, flexible and costeffective facility. During the study
period, NIH expanded the building
program to also include space for the
National Heart, Lung & Blood Institute’s
(NHLBI) Cardiovascular Intervention
Program (Cath Lab) and for the
Interventional Radiology (IR) Program.
The proposed project consists of nine
(9) levels above grade (including
interstitial floors and a roof penthouse)
and two (2) levels below grade. The
proposed 505,200 building gross square
feet (BGSF) of new construction will be
linked to the west lab wing of the
existing CRC (Building 10), which will
include an additional 82,960 BGSF of
interior renovation. The proposed new
building addition foot print of 53,270
BGSF will be positioned between the
CRC and Convent Drive.
The proposed project scope also
includes the relocation of a portion of
the existing campus utility tunnel,
reconstruction of the displaced
children’s playground and connection
to the new Pedestrian Tunnel that will
be constructed with the proposed
Patient Parking Garage across Convent
Drive. Additionally, the project will
include the installation of supporting
infrastructure, such as emergency
generators and medical gas storage, in
the new Utility Vault and Utility Yard
that will be constructed across Convent
Drive as part of a separate, enabling
project.
In accordance with 40 CFR 1500–1508
and Health and Human Services (HHS)
environmental procedures, NIH will
prepare an Environmental Impact
Statement (EIS) for the proposed project.
The EIS will evaluate the impacts of the
alternatives should development occur
as proposed. Among the items the EIS
will examine are the implications of the
project on community infrastructure,
including, but not limited to, utilities,
storm water management, traffic and
transportation, and other public
services.
To ensure that the public is afforded
the greatest opportunity to participate in
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56087-56088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24604]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-2506]
Determination That AXIRON (Testosterone) Transdermal Metered
Solution, 30 Milligrams/1.5 Milliliter Actuation, 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 AXIRON (testosterone) transdermal metered solution, 30
milligrams (mg)/1.5 milliliter (mL) actuation, 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
if 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.
AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL
actuation, is the subject of NDA 022504, held by Eli Lilly and Company
and initially approved on November 23, 2010. AXIRON is indicated for
replacement therapy in males for conditions associated with a
deficiency or absence of endogenous testosterone.
In a letter dated September 5, 2017, Eli Lilly and Company
requested withdrawal of NDA 022504 for AXIRON (testosterone). Eli Lilly
and Company later submitted a letter dated September 7, 2017 correcting
a typographical error in the September 5, 2017 letter. In the Federal
Register of June 21, 2018 (83 FR 28856), FDA announced that it was
withdrawing approval of NDA 022504, effective July 23, 2018.
K&L Gates LLP submitted a citizen petition received by FDA on June
27,
[[Page 56088]]
2018 (Docket No. FDA-2018-P-2506), under 21 CFR 10.25 and 21 CFR 10.30,
requesting that the Agency determine whether AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5 mL actuation, 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 AXIRON (testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that AXIRON (testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, was withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of AXIRON (testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, 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 AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5 mL actuation, 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 that refer to 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: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24604 Filed 11-8-18; 8:45 am]
BILLING CODE 4164-01-P
