[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51324-51325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16537]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-2339]


Determination That K-TAB (Potassium Chloride) Extended-Release 
Tablets, 10 Milliequivalents and 20 Milliequivalents, Were Not 
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that K-TAB (potassium chloride) extended-release tablets, 10 
milliequivalents and 20 milliequivalents, were not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for potassium 
chloride extended-release tablets, 10 milliequivalents (meqs) and 20 
meqs, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Veniqua Stewart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3627, [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.
    K-TAB (potassium chloride) extended-release tablets, 10 meqs and 20 
meqs, are two of the subjects of NDA 018279, held by AbbVie Inc. The 
NDA was initially approved on June 9, 1980. K-TAB is indicated for the 
treatment and prophylaxis of hypokalemia with or without metabolic 
alkalosis in patients for whom dietary management with potassium-rich 
foods or diuretic dose reduction is insufficient.
    The K-TAB (potassium chloride) extended-release tablets, 10 meqs 
and 20 meqs, are currently listed in the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Granules India Ltd. submitted a citizen petition dated June 8, 2023 
(Docket No. FDA-2023-P-2339), under 21 CFR 10.30, requesting that the 
Agency determine whether K-TAB (potassium chloride) extended-release 
tablets, 10 meqs and 20 meqs, 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 K-TAB (potassium chloride) extended-release 
tablets, 10 meqs and 20 meqs, were not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that K-TAB (potassium chloride) extended-release 
tablets, 10 meqs and 20 meqs, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of K-TAB (potassium chloride) extended-
release tablets, 10 meqs and 20 meqs, 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 these drug products were not withdrawn from sale 
for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list K-TAB (potassium

[[Page 51325]]

chloride) extended-release tablets, 10 meqs and 20 meqs, 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 these drug products 
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 products should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16537 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P