[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Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons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milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn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