[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24107-24108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-3299]


Determination That THALITONE (Chlorthalidone USP) Tablets, 15 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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 THALITONE (chlorthalidone USP) tablets, 15 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(mg), were not withdrawn from sale for reasons of safety or 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

[[Page 24108]]

chlorthalidone USP tablets, 15 mg, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240-
402-3543.

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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.
    THALITONE (chlorthalidone USP) tablets, 15 mg, are the subject of 
NDA 19-574, held by Citron Pharma LLC, and initially approved on 
December 20, 1988. THALITONE is indicated for the management of 
hypertension either alone or in combination with other antihypertensive 
drugs. Chlorthalidone is indicated as an adjunctive therapy in edema 
associated with congestive heart failure, hepatic cirrhosis, and 
corticosteroid and estrogen therapy. Chlorthalidone has also been found 
useful in edema due to various forms of renal dysfunction such as 
nephrotic syndrome, acute glomerulonephritis, and chronic renal 
failure.
    THALITONE (chlorthalidone USP) tablets, 15 mg, are currently listed 
in the ``Discontinued Drug Product List'' section of the Orange Book.
    Clinipace Worldwide submitted a citizen petition dated September 9, 
2015 (Docket No. FDA-2015-P-3299), under 21 CFR 10.30, requesting that 
the Agency determine whether THALITONE (chlorthalidone USP) tablets, 15 
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, FDA has determined under Sec.  314.161 
that THALITONE (chlorthalidone USP) tablets, 15 mg, were not withdrawn 
for reasons of safety or effectiveness. The petitioner has identified 
no data or other information suggesting that THALITONE (chlorthalidone 
USP) tablets, 15 mg, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of THALITONE (chlorthalidone USP) tablets, 15 
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 THALITONE 
(chlorthalidone USP) tablets, 15 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 THALITONE (chlorthalidone USP) 
tablets, 15 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: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09450 Filed 4-22-16; 8:45 am]
 BILLING CODE 4164-01-P