[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]


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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Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn 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.

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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milligrams (mg)/1.5 milliliter (mL) actuation, was not withdrawn from 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