Notice2021-16037
Determination That EFUDEX (Fluorouracil) Topical Solution, 5 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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and Drug Administration (FDA or Agency) has determined that EFUDEX (fluorouracil) topical solution, 5 percent, was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40566-40567]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16037]
=======================================================================
-----------------------------------------------------------------------
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Percent, Was Not Withdrawn From Sale for Reasons of Safety or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.
-----------------------------------------------------------------------
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not withdrawn from sale for reasons of safety or effectiveness.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, <a href="/cdn-cgi/l/email-protection#713a1014051e1219185f3e1a141c16131e311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="f0bb9195849f939899debf9b959d97929fb0969491de989883de979f86">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 28, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.