Notice2023-22464
Determination That MEKINIST (Trametinib Dimethyl Sulfoxide) Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
October 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) has determined that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for trametinib dimethyl sulfoxide tablets, 1 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70673-70674]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22464]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-1795]
Determination That MEKINIST (Trametinib Dimethyl Sulfoxide)
Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety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 the Agency) has
determined that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1
milligram (mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for trametinib dimethyl sulfoxide
tablets, 1 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-
796-3601, <a href="/cdn-cgi/l/email-protection#9dd3f4fef2f1f8b3d0e8f8f1f1f8efddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="7d33141e121118533008181111180f3d1b191c5315150e531a120b">[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.
MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, is the
subject of NDA 204114, held by Novartis Pharmaceuticals Corp., and
initially approved on May 29, 2013. MEKINIST is a kinase inhibitor
indicated as a single agent for the treatment of BRAF-inhibitor
treatment-na[iuml]ve patients with unresectable or metastatic melanoma
with BRAF V600E or V600K mutations as detected by an FDA-approved test.
[[Page 70674]]
MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book. Apotex Inc., submitted a citizen petition dated May 4,
2023 (Docket No. FDA-2023-P-1795), under 21 CFR 10.30, requesting that
the Agency determine whether MEKINIST (trametinib dimethyl sulfoxide)
tablets, 1 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 MEKINIST (trametinib dimethyl sulfoxide)
tablets, 1 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that MEKINIST (trametinib dimethyl sulfoxide)
tablets, 1 mg, was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 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 MEKINIST (trametinib
dimethyl sulfoxide) tablets, 1 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 MEKINIST (trametinib dimethyl
sulfoxide) tablets, 1 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: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22464 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
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