[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27436-27437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0226]


Determination That AVACLYR (Acyclovir Ophthalmic Ointment), 3 
Percent, Was Not Withdrawn From Sale for Reasons of Safety or 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 AVACLYR (acyclovir ophthalmic ointment), 3 percent, was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for acyclovir ophthalmic ointment, 3 percent, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455, 
[email protected].

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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.
    AVACLYR (acyclovir ophthalmic ointment), 3 percent, is the subject 
of NDA 202408, held by Fera Pharmaceuticals, LLC, and initially 
approved on March 29, 2019. AVACLYR is indicated for the treatment of 
acute herpetic keratitis (dendritic ulcers) in patients with herpes 
simplex (HSV-1 and HSV-2) virus.
    In a letter dated August 21, 2019, Fera Pharmaceuticals, LLC 
notified FDA that AVACLYR (acyclovir ophthalmic ointment), 3 percent, 
was being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Cumulus Pharmaceutical LLC submitted a citizen petition dated 
February 23, 2021, (Docket No. FDA-2021-P-0226), under 21 CFR 10.30, 
requesting that the Agency determine whether AVACLYR (acyclovir 
ophthalmic ointment), 3 percent, 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 AVACLYR (acyclovir ophthalmic ointment), 3 
percent, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
AVACLYR (acyclovir ophthalmic ointment), 3 percent, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of AVACLYR (acyclovir 
ophthalmic ointment), 3 percent, 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 AVACLYR (acyclovir 
ophthalmic ointment), 3 percent, 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. Any ANDAs referencing AVACLYR (acyclovir ophthalmic 
ointment), 3 percent, 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 to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.


[[Page 27437]]


    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10593 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P