Notice2024-19721
Determination That FLAGYL (Metronidazole) Tablets, 250 Milligrams and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 4, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that FLAGYL (metronidazole) tablets, 250 milligrams (mg) and 500 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 89 Issue 171 (Wednesday, September 4, 2024)</title>
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[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Page 71907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19721]
[[Page 71907]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-2513]
Determination That FLAGYL (Metronidazole) Tablets, 250 Milligrams
and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety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 FLAGYL (metronidazole) tablets, 250 milligrams (mg) and
500 mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to these products as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Neerja Razdan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-3600, <a href="/cdn-cgi/l/email-protection#48062d2d3a2229661a29322c2926082e2c296620203b662f273e"><span class="__cf_email__" data-cfemail="3c7259594e565d126e5d46585d527c5a585d1254544f125b534a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
FLAGYL (metronidazole) tablets, 250 mg and 500 mg, are the subject
of NDA 012623, held by Pfizer, Inc., and initially approved prior to
Jan 1, 1982. FLAGYL is indicated for treatment of symptomatic
Trichomoniasis, asymptomatic Trichomoniasis, treatment of asymptomatic
sexual partners, Amebiasis, anaerobic bacterial infections among other
infections, as listed on the product label, and as clinically indicated
for treatment.
FLAGYL (metronidazole) tablets, 250 mg and 500 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Innogenix LLC submitted a citizen petition dated May 21, 2024
(Docket No. FDA-2024-P-2513), under 21 CFR 10.30, requesting that the
Agency determine whether FLAGYL (metronidazole) tablets, 250 mg and 500
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 FLAGYL (metronidazole) tablets, 250 mg and 500
mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
FLAGYL (metronidazole) tablets, 250 mg and 500 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of FLAGYL (metronidazole)
tablets, 250 milligrams and 500 milligrams, 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 these drug products were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list FLAGYL
(metronidazole) tablets, 250 mg and 500 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
these drug products 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 these drug products should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19721 Filed 9-3-24; 8:45 am]
BILLING CODE 4164-01-P
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