[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37158-37159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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were not withdrawn from sale for reasons of safety or effectiveness.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, 
Christopher.Koepke@fda.hhs.gov.

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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


