83 FR 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Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 218 (November 9, 2018)

Page Range		56087-56088
FR Document		2018-24604

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that AXIRON (testosterone) transdermal metered solution, 30 milligrams (mg)/1.5 milliliter (mL) actuation, was not withdrawn from sale for reasons of safety or effectiveness.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.

Federal Register, Volume 83 Issue 218 (Friday, November 9, 2018)

[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56087-56088]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24604]


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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Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn 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milligrams (mg)/1.5 milliliter (mL) actuation, was not withdrawn from 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

Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices 56087

Application No. Drug Applicant

ANDA 040747 ...................... Benzphetamine Hydrochloride (HCl) Tablets, 25 milli- Tedor Pharma, Inc., 400 Highland Corporate Dr., Cum-
grams (mg) and 50 mg. berland, RI 02864.
ANDA 062356 ...................... Gentamicin Sulfate Injection USP, Equivalent to (EQ) Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
10 mg base/milliliter (mL) and EQ 40 mg base/mL. Zurich, IL 60047.
ANDA 074097 ...................... Isoflurane USP, 99.9% .................................................... Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake For-
est, IL 60045.
ANDA 076484 ...................... Ciprofloxacin Injection USP, 200 mg/20 mL and 400 Fresenius Kabi USA, LLC.
mg/40 mL.
ANDA 080504 ...................... Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL; Belmora LLC, 2231 Crystal Dr., #1000, Arlington, VA
2% and 0.02 mg/mL; 2%. 22202.
Lidocaine HCl Injection, 2%.
ANDA 083559 ...................... Mepivacaine HCl Injection, 3% ....................................... Do.
ANDA 084315 ...................... Dexamethasone Acetate Injectable Suspension USP, Watson Laboratories, Inc., Subsidiary of Teva Pharma-
EQ 8 mg base/mL. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
ANDA 084850 ...................... Levonordefrin and Mepivacaine HCl Injection, 2%; 0.05 Belmora LLC.
mg/mL.
ANDA 086389 ...................... Lidocaine HCl Viscous Oral Topical Solution USP, 2% International Medication Systems, Ltd., 1886 Santa
Anita Ave., South El Monte, CA 91733.
ANDA 087863 ...................... Choledyl SA (oxtriphylline) Extended-Release Tablets Warner Chilcott Co., LLC, Subsidiary of Teva Pharma-
USP, 400 mg. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.

Therefore, approval of the transdermal metered solution, 30 Therapeutic Equivalence Evaluations,’’
applications listed in the table, and all milligrams (mg)/1.5 milliliter (mL) which is known generally as the
amendments and supplements thereto, actuation, was not withdrawn from sale ‘‘Orange Book.’’ Under FDA regulations,
is hereby withdrawn as of December 10, for reasons of safety or effectiveness. drugs are removed from the list if the
2018. Introduction or delivery for This determination means that FDA will Agency withdraws or suspends
introduction into interstate commerce of not begin procedures to withdraw approval of the drug’s NDA or ANDA
products without approved new drug approval of abbreviated new drug for reasons of safety or effectiveness or
applications violates section 301(a) and applications (ANDAs) that refer to this if FDA determines that the listed drug
(d) of the Federal Food, Drug, and drug product, and it will allow FDA to was withdrawn from sale for reasons of
Cosmetic Act (21 U.S.C. 331(a) and (d)). continue to approve ANDAs that refer to safety or effectiveness (21 CFR 314.162).
Drug products that are listed in the table the product if they meet relevant legal A person may petition the Agency to
that are in inventory on December 10, and regulatory requirements. determine, or the Agency may
2018 may continue to be dispensed FOR FURTHER INFORMATION CONTACT: determine on its own initiative, whether
until the inventories have been depleted Stacy Kane, Center for Drug Evaluation a listed drug was withdrawn from sale
or the drug products have reached their and Research, Food and Drug for reasons of safety or effectiveness.
expiration dates or otherwise become Administration, 10903 New Hampshire This determination may be made at any
violative, whichever occurs first. Ave., Bldg. 51, Rm. 6236, Silver Spring, time after the drug has been withdrawn
Dated: November 6, 2018. MD 20993–0002, 301–796–8363. from sale, but must be made prior to
Leslie Kux, SUPPLEMENTARY INFORMATION: In 1984, approving an ANDA that refers to the
Congress enacted the Drug Price listed drug (§ 314.161 (21 CFR 314.161)).
Associate Commissioner for Policy.
Competition and Patent Term FDA may not approve an ANDA that
[FR Doc. 2018–24605 Filed 11–8–18; 8:45 am]
Restoration Act of 1984 (Pub. L. 98–417) does not refer to a listed drug.
BILLING CODE 4164–01–P
(the 1984 amendments), which AXIRON (testosterone) transdermal
authorized the approval of duplicate metered solution, 30 mg/1.5 mL
versions of drug products under an actuation, is the subject of NDA 022504,
DEPARTMENT OF HEALTH AND
ANDA procedure. ANDA applicants held by Eli Lilly and Company and
HUMAN SERVICES
must, with certain exceptions, show that initially approved on November 23,
Food and Drug Administration the drug for which they are seeking 2010. AXIRON is indicated for
approval contains the same active replacement therapy in males for
[Docket No. FDA–2018–P–2506] ingredient in the same strength and conditions associated with a deficiency
dosage form as the ‘‘listed drug,’’ which or absence of endogenous testosterone.
Determination That AXIRON
is a version of the drug that was In a letter dated September 5, 2017,
(Testosterone) Transdermal Metered
previously approved. ANDA applicants Eli Lilly and Company requested
Solution, 30 Milligrams/1.5 Milliliter
do not have to repeat the extensive withdrawal of NDA 022504 for AXIRON
Actuation, Was Not Withdrawn From
clinical testing otherwise necessary to (testosterone). Eli Lilly and Company
Sale for Reasons of Safety or
gain approval of a new drug application later submitted a letter dated September
Effectiveness
7, 2017 correcting a typographical error
khammond on DSK30JT082PROD with NOTICES

(NDA).
AGENCY: Food and Drug Administration, The 1984 amendments include what in the September 5, 2017 letter. In the
HHS. is now section 505(j)(7) of the Federal Federal Register of June 21, 2018 (83 FR
ACTION: Notice. Food, Drug, and Cosmetic Act (21 U.S.C. 28856), FDA announced that it was
355(j)(7)), which requires FDA to withdrawing approval of NDA 022504,
SUMMARY: The Food and Drug publish a list of all approved drugs. effective July 23, 2018.
Administration (FDA or Agency) has FDA publishes this list as part of the K&L Gates LLP submitted a citizen
determined that AXIRON (testosterone) ‘‘Approved Drug Products With petition received by FDA on June 27,

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56088 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices

2018 (Docket No. FDA–2018–P–2506), DEPARTMENT OF HEALTH AND enhance health, lengthen life, and
under 21 CFR 10.25 and 21 CFR 10.30, HUMAN SERVICES reduce illness and disability. In order to
requesting that the Agency determine fulfill and uphold this mission the
whether AXIRON (testosterone) National Institutes of Health infrastructure of the NIH Bethesda
transdermal metered solution, 30 mg/1.5 Campus must be able to support the
Notice of Intent To Prepare an NIH’s biomedical research programs.
mL actuation, was withdrawn from sale Environmental Impact Statement and
for reasons of safety or effectiveness. The proposed Surgery, Radiology and
Notice of Scoping Meeting Lab Medicine Building with associated
After considering the citizen petition Utility Vault and Patient Parking Garage
AGENCY: National Institutes of Health,
and reviewing Agency records and project is to house General Radiology
HHS.
based on the information we have at this and Imaging Services (RADIS), the
time, FDA has determined under ACTION: Notice.
Department of Perioperative Medicine
§ 314.161 that AXIRON (testosterone) SUMMARY: In accordance with the (DPM), the Department of Laboratory
transdermal metered solution, 30 mg/1.5 National Environmental Policy Act, the Medicine (DLM) and the relocated
mL actuation, was not withdrawn for National Institutes of Health (NIH) is functions for the National Cancer
reasons of safety or effectiveness. The issuing this notice to advise the public Institute (NCI) in a state-of-the-art, safe,
petitioner has identified no data or other that an environmental impact statement functionally efficient, flexible and cost-
information suggesting that AXIRON will be prepared for the Surgery, effective facility. During the study
(testosterone) transdermal metered Radiology and Lab Medicine Building period, NIH expanded the building
solution, 30 mg/1.5 mL actuation, was with associated Utility Vault and Patient program to also include space for the
withdrawn for reasons of safety or Parking Garage project located on the National Heart, Lung & Blood Institute’s
effectiveness. We have carefully National Institutes of Health, Bethesda (NHLBI) Cardiovascular Intervention
reviewed our files for records Campus, Bethesda, Maryland. Program (Cath Lab) and for the
DATES: The Scoping Meeting is planned Interventional Radiology (IR) Program.
concerning the withdrawal of AXIRON
for November 28, 2018, from 6 p.m.-9 The proposed project consists of nine
(testosterone) transdermal metered (9) levels above grade (including
solution, 30 mg/1.5 mL actuation, from p.m., with the formal presentation to
begin at 7 p.m. Scoping comments must interstitial floors and a roof penthouse)
sale. We have also independently and two (2) levels below grade. The
be postmarked no later than December
evaluated relevant literature and data proposed 505,200 building gross square
29, 2018, to ensure they are considered.
for possible postmarketing adverse feet (BGSF) of new construction will be
ADDRESSES: The Scoping Meeting will
events. We have found no information linked to the west lab wing of the
be held at 6001 Executive Boulevard,
that would indicate that this drug existing CRC (Building 10), which will
Rockville, MD 20852. All comments and
product was withdrawn from sale for include an additional 82,960 BGSF of
questions on the Scoping Meeting and
reasons of safety or effectiveness. the Environmental Impact Statement interior renovation. The proposed new
Accordingly, the Agency will should be directed to Valerie building addition foot print of 53,270
continue to list AXIRON (testosterone) BGSF will be positioned between the
Nottingham, Deputy Director, Division
transdermal metered solution, 30 mg/1.5 CRC and Convent Drive.
of Environmental Protection, Office of
The proposed project scope also
mL actuation, in the ‘‘Discontinued Research Facilities, NIH, B13/2S11, includes the relocation of a portion of
Drug Product List’’ section of the Orange 9000 Rockville Pike, Bethesda, the existing campus utility tunnel,
Book. The ‘‘Discontinued Drug Product Maryland 20892, telephone 301–496– reconstruction of the displaced
List’’ delineates, among other items, 7775; fax 301–480–0204; or email: children’s playground and connection
drug products that have been nihnepa@mail.nih.gov. to the new Pedestrian Tunnel that will
discontinued from marketing for reasons FOR FURTHER INFORMATION CONTACT: be constructed with the proposed
other than safety or effectiveness. FDA Valerie Nottingham, Deputy Director, Patient Parking Garage across Convent
will not begin procedures to withdraw Division of Environmental Protection, Drive. Additionally, the project will
approval of approved ANDAs that refer Office of Research Facilities, NIH, B13/ include the installation of supporting
to this drug product. Additional ANDAs 2S11, 9000 Rockville Pike, Bethesda, infrastructure, such as emergency
that refer to this drug product may also Maryland 20892, telephone 301–496– generators and medical gas storage, in
be approved by the Agency as long as 7775; fax 301–480–0204; or email: the new Utility Vault and Utility Yard
they meet all other legal and regulatory nihnepa@mail.nih.gov. For the purpose that will be constructed across Convent
requirements for the approval of of National Institutes of Health (NIH) Drive as part of a separate, enabling
and its National Environmental Policy project.
ANDAs. If FDA determines that labeling
Act (NEPA) procedures, the delegation In accordance with 40 CFR 1500–1508
for this drug product should be revised
of authority to administer, interpret and and Health and Human Services (HHS)
to meet current standards, the Agency
oversee the applicable environmental environmental procedures, NIH will
will advise ANDA applicants to submit laws, Executive Orders and regulations
such labeling. prepare an Environmental Impact
for the NIH including the authority to Statement (EIS) for the proposed project.
Dated: November 5, 2018. oversee and manage the NIH NEPA The EIS will evaluate the impacts of the
Leslie Kux, program for assessing environmental alternatives should development occur
Associate Commissioner for Policy. impacts and publish final decisions has as proposed. Among the items the EIS
been given to the Director, Office of
khammond on DSK30JT082PROD with NOTICES

[FR Doc. 2018–24604 Filed 11–8–18; 8:45 am] will examine are the implications of the
Research Facilities Development and project on community infrastructure,
BILLING CODE 4164–01–P
Operation, Mr. Daniel G. Wheeland. including, but not limited to, utilities,
SUPPLEMENTARY INFORMATION: The NIH’s storm water management, traffic and
mission is to seek fundamental transportation, and other public
knowledge about the nature and services.
behavior of living systems and the To ensure that the public is afforded
application of that knowledge to the greatest opportunity to participate in

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Document Created: 2018-11-09 03:33:49
Document Modified: 2018-11-09 03:33:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		83 FR 56087

83 FR 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 218 (November 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration