[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70673-70674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety 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milligram (mg), was not withdrawn from sale for reasons of safety or 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, [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FDA determines that the listed drug was withdrawn from sale for reasons 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.
    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