[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35648-35649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16031]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-1283]
Determination That Metaxalone Tablets, 640 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 metaxalone tablets, 640 milligrams (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withdrawn from sale for reasons of safety or effectiveness.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 metaxalone tablets, 640 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Glen Cheng, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-796-1494.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
Metaxalone tablets, 640 mg, are the subject of NDA 22-503, held by
Primus Pharmaceuticals, Inc., and initially approved on June 1, 2015.
Metaxalone tablets, 640 mg, are indicated as an adjunct to rest,
physical therapy, and other measures for the relief of discomfort
associated with acute, painful musculoskeletal conditions.
In a letter dated September 30, 2015, the previous NDA holder
CorePharma, LLC notified FDA that metaxalone tablets, 640 mg, were
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Sovereign Pharmaceuticals, LLC submitted a citizen petition dated
March 26, 2018 (Docket No. FDA-2018-P-1283), under 21 CFR 10.30,
requesting that the Agency determine whether metaxalone tablets, 640
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 metaxalone tablets, 640 mg, were not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that metaxalone tablets, 640
mg, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
metaxalone tablets, 640 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 35649]]
not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list metaxalone tablets,
640 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
metaxalone tablets, 640 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: July 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16031 Filed 7-26-18; 8:45 am]
BILLING CODE 4164-01-P