[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Page 71907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19721]



[[Page 71907]]

-----------------------------------------------------------------------

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and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety 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.

-----------------------------------------------------------------------

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500 mg, were not withdrawn from sale for reasons of safety or 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, [email protected].

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