Notice2023-16537
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That K-TAB (Potassium Chloride) Extended-Release Tablets, 10 Milliequivalents and 20 Milliequivalents, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
August 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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that K-TAB (potassium chloride) extended-release tablets, 10 milliequivalents and 20 milliequivalents, were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 88 Issue 148 (Thursday, August 3, 2023)</title>
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[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51324-51325]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16537]
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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Withdrawn From Sale for Reasons of Safety or Effectiveness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.
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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milliequivalents and 20 milliequivalents, were not withdrawn from sale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, <a href="/cdn-cgi/l/email-protection#9ceaf9f2f5ede9fdb2efe8f9ebfdeee8dcfaf8fdb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="097f6c6760787c68277a7d6c7e687b7d496f6d682761617a276e667f">[email protected]</span></a>.
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
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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
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