[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18945-18946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-P-0827]


Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 
Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons 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 DUEXIS (ibuprofen and famotidine) tablet, 800 
milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn 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 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: Grace St. Vincent, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 240-
402-9201, [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.
    DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, is 
the subject of NDA 022519, held by Horizon Medicines LLC, and initially 
approved on April 23, 2011. DUEXIS is indicated for the relief of signs 
and symptoms of rheumatoid arthritis and osteoarthritis and to decrease 
the risk of developing upper gastrointestinal ulcers in patients who 
are taking ibuprofen for those indications.
    In a letter dated August 10, 2023, Horizon Medicines LLC notified 
FDA

[[Page 18946]]

that DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, was 
being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Aurobindo Pharma USA, Inc., submitted a citizen petition dated 
February 14, 2024 (Docket No. FDA-2024-P-0827), under 21 CFR 10.30, 
requesting that the Agency determine whether DUEXIS (ibuprofen and 
famotidine) tablet, 800 mg and 26.6 mg, 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 DUEXIS (ibuprofen and famotidine) tablet, 800 
mg and 26.6 mg, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that DUEXIS (ibuprofen and famotidine) tablet, 
800 mg and 26.6 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of DUEXIS (ibuprofen and famotidine) tablet, 
800 mg and 26.6 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 DUEXIS (ibuprofen and 
famotidine) tablet, 800 mg and 26.6 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product 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: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05578 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P