[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58722-58723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-2982]


Determination That MEXITIL (Mexiletine Hydrochloride) Capsules, 
150 Milligrams, 200 Milligrams, and 250 Milligrams, Were Not Withdrawn 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, Agency, or we) has 
determined that MEXITIL (mexiletine hydrochloride) capsules, 150 
milligrams (mg), 200 mg, and 250 mg, were not withdrawn from sale for 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 MEXITIL 
(mexiletine hydrochloride) capsules, 150 mg, 200 mg, and 250 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Carlarease Hunter, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3702, [email protected].

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

[[Page 58723]]

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.
    MEXITIL (mexiletine hydrochloride) is the subject of NDA 018873, 
held by Boehringer Ingelheim Pharmaceuticals, Inc., and initially 
approved on December 30, 1985. MEXITIL (mexiletine hydrochloride) 
capsules, 150 mg, 200 mg, and 250 mg, are indicated for the treatment 
of documented ventricular arrhythmias, such as sustained ventricular 
tachycardia, that, in the judgment of the physician, are life-
threatening.
    MEXITIL (mexiletine hydrochloride) capsules, 150 mg, 200 mg, and 
250 mg, are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Hetero Labs Limited submitted a citizen petition dated June 19, 
2019 (Docket No. FDA-2019-P-2982), under 21 CFR 10.30, requesting that 
the Agency determine whether MEXITIL (mexiletine hydrochloride) 
capsules, 150 mg, 200 mg, and 250 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 MEXITIL (mexiletine hydrochloride) capsules, 
150 mg, 200 mg, and 250 mg, were not withdrawn for reasons of safety or 
effectiveness.
    The petitioner has identified no data or other information 
suggesting that MEXITIL (mexiletine hydrochloride) capsules, 150 mg, 
200 mg, and 250 mg, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of MEXITIL (mexiletine hydrochloride) 
capsules, 150 mg, 200 mg, and 250 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 not withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MEXITIL (mexiletine 
hydrochloride) capsules, 150 mg, 200 mg, and 250 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 MEXITIL (mexiletine 
hydrochloride) capsules, 150 mg, 200 mg, and 250 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 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23923 Filed 10-31-19; 8:45 am]
BILLING CODE 4164-01-P