[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Page 17159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-1881]


Determination That SERENTIL (Mesoridazine Besylate) Tablets, 10 
Milligrams, 25 Milligrams, 50 Milligrams, and 100 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Withdrawn From Sale for Reasons of Safety or Effectiveness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, the Agency, or we) has 
determined that SERENTIL (mesoridazine besylate) tablets, 10 milligrams 
(mg), 25 mg, 50 mg, and 100 mg, were not withdrawn from sale for 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 mesoridazine 
besylate tablets, 10 mg, 25 mg, 50 mg, and 100 mg, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-402-4191, 
[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 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.
    SERENTIL (mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 
100 mg, are the subject of NDA 16774, held by Norvartis Pharmaceuticals 
Corporation, and initially approved on February 27, 1970. SERENTIL is 
indicated for the management of schizophrenic patients who fail to 
respond adequately to treatment with other antipsychotic drugs.
    In a letter dated September 9, 2008, Novartis Pharmaceuticals 
Corporation requested withdrawal of NDA 16774 for SERENTIL 
(mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 100 mg. In 
the Federal Register of February 22, 2018 (83 FR 7738), FDA announced 
that it was withdrawing approval of NDA 16774, effective March 26, 
2018.
    The Weinberg Group submitted a citizen petition dated September 15, 
2020 (Docket No. FDA-2020-P-1881), under 21 CFR 10.30, requesting that 
the Agency determine whether SERENTIL (mesoridazine besylate) tablets, 
10 mg, 25 mg, 50 mg, and 100 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 SERENTIL (mesoridazine besylate) tablets, 10 
mg, 25 mg, 50 mg, and 100 mg, were not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that SERENTIL (mesoridazine besylate) tablets, 
10 mg, 25 mg, 50 mg, and 100 mg, were withdrawn for reasons of safety 
or effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of SERENTIL (mesoridazine besylate) tablets, 
10 mg, 25 mg, 50 mg, and 100 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 SERENTIL 
(mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 100 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 SERENTIL 
(mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 100 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: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06722 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P