Notice2021-14935
Determination That STROMECTOL (Ivermectin) Tablets, 6 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
July 14, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that STROMECTOL (ivermectin) tablets, 6 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for STROMECTOL (ivermectin) tablets, 6 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 86 Issue 132 (Wednesday, July 14, 2021)</title>
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[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37158-37159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14935]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0191]
Determination That STROMECTOL (Ivermectin) Tablets, 6 Milligrams,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 STROMECTOL (ivermectin) tablets, 6 milligrams (mg),
were not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for STROMECTOL (ivermectin) tablets, 6 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3600,
<a href="/cdn-cgi/l/email-protection#cb88a3b9a2b8bfa4bba3aeb9e580a4aebba0ae8badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="c784afb5aeb4b3a8b7afa2b5e98ca8a2b7aca287a1a3a6e9afafb4e9a0a8b1">[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).
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.
STROMECTOL (ivermectin) tablets, 6 mg, are the subject of NDA
050742, held by Merck Sharp and Dohme Corp., and initially approved on
November 22, 1996. STROMECTOL is indicated for strongyloidiasis of the
intestinal tract and onchocerciasis.
In a letter dated September 14, 2007, Merck and Co., Inc. notified
FDA that STROMECTOL (ivermectin) tablets, 6 mg, were being
discontinued, and FDA
[[Page 37159]]
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
Foley and Lardner, LLP submitted a citizen petition dated February
16, 2021 (Docket No. FDA-2021-P-0191), under 21 CFR 10.30, requesting
that the Agency determine whether STROMECTOL (ivermectin) tablets, 6
mg, were 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 STROMECTOL (ivermectin) tablets, 6 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that STROMECTOL
(ivermectin) tablets, 6 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of STROMECTOL (ivermectin) tablets, 6 mg,
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 STROMECTOL
(ivermectin) tablets, 6 mg, 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. ANDAs that refer to STROMECTOL (ivermectin) tablets, 6
mg, 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.
Dated: July 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14935 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P
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