Notice2024-02710
Determination That QMIIZ (Meloxicam) Orally Disintegrating Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
February 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 89 Issue 28 (Friday, February 9, 2024)</title>
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[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Pages 9156-9157]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02710]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-4279]
Determination That QMIIZ (Meloxicam) Orally Disintegrating
Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale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 QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5
milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of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 QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3507, <a href="/cdn-cgi/l/email-protection#2f61464c40434a01625a4a43434a5d6f494b4e0147475c01484059"><span class="__cf_email__" data-cfemail="cc82a5afa3a0a9e281b9a9a0a0a9be8caaa8ade2a4a4bfe2aba3ba">[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.
QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg,
are the subject of NDA 211210, held by TerSera Therapeutics LLC
(TerSera), and initially approved on October 19, 2018. QMIIZ is a non-
steroidal anti-inflammatory indicated for osteoarthritis in adults,
rheumatoid arthritis in adults, and pauciarticular or polyarticular
course juvenile rheumatoid arthritis in pediatric patients who weigh
greater than or equal to 60 kilograms.
In a letter dated March 24, 2021, TeraSera notified FDA that QMIIZ
(meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg, were being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Pharmobedient Consulting submitted a citizen petition dated
September 27, 2023 (Docket No. FDA-2023-P-4279), under 21 CFR 10.30,
requesting that the Agency determine whether QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15 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 QMIIZ (meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that QMIIZ (meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of QMIIZ (meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 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
[[Page 9157]]
not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list QMIIZ (meloxicam)
Orally Disintegrating Tablets, 7.5 mg and 15 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 QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15 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: February 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02710 Filed 2-8-24; 8:45 am]
BILLING CODE 4164-01-P
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