[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Page 16691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06783]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-5304]
Determination That MOBIC (Meloxicam) 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15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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 MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15
mg, were not withdrawn from sale for reasons of safety or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 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: Beth Holck, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 240-402-7133,
[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
(21 CFR 314.161). FDA may not approve an ANDA that does not refer to a
listed drug.
MOBIC (meloxicam) tablets, 7.5 mg and 15 mg, are the subject of NDA
020938, held by Boehringer Ingelheim Pharmaceuticals, Inc., and
initially approved on April 13, 2000. MOBIC is indicated for relief of
the signs and symptoms of osteoarthritis, rheumatoid arthritis, and
juvenile rheumatoid arthritis in patients who weigh more than 60
kilograms.
MOBIC (meloxicam) tablets, 7.5 mg and 15 mg, are currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
Pharmobedient Consulting, LLC submitted a citizen petition dated
November 8, 2024 (Docket No. FDA-2024-P-5304), under 21 CFR 10.30,
requesting that the Agency determine whether MOBIC (meloxicam) 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 MOBIC (meloxicam) 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
MOBIC (meloxicam) 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 MOBIC (meloxicam) 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
found no information that would indicate that this drug product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list MOBIC (meloxicam)
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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to these drug products. 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: April 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-06783 Filed 4-18-25; 8:45 am]
BILLING CODE 4164-01-P