[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40566-40567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0299]


Determination That EFUDEX (Fluorouracil) Topical Solution, 5 
Percent, Was Not Withdrawn From Sale for Reasons of Safety or 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 EFUDEX (fluorouracil) topical solution, 5 percent, was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of the abbreviated new drug application (ANDA) that refers 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: Kaetochi Okemgbo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 240-
825-9944, [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).

[[Page 40567]]

    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.
    EFUDEX (fluorouracil) topical solution, 5 percent, is the subject 
of NDA 016831, held by Bausch Health Americas, Inc., and initially 
approved on July 29, 1970. EFUDEX is indicated for the topical 
treatment of multiple actinic or solar keratoses, and treatment of 
superficial basal cell carcinomas when conventional methods are 
impractical, such as with multiple lesions or difficult treatment 
sites. EFUDEX (fluorouracil) topical solution, 5 percent, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Encube Ethicals Private Ltd. submitted a citizen petition dated 
March 16, 2021 (Docket No. FDA-2021-P-0299), under 21 CFR 10.30, 
requesting that the Agency determine whether EFUDEX (fluorouracil) 
topical solution, 5 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 EFUDEX (fluorouracil) topical solution, 5 
percent, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
EFUDEX (fluorouracil) topical solution, 5 percent, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of EFUDEX (fluorouracil) 
topical solution, 5 percent, 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 EFUDEX (fluorouracil) 
topical solution, 5 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. FDA will not begin procedures to withdraw approval of 
the approved ANDA that refers to this drug product. Additional ANDAs 
that refer to EFUDEX (fluorouracil) topical solution, 5 percent, 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: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16037 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P