88 FR 148 pgs. 51324-51325 - 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That K-TAB (Potassium Chloride) Extended-Release Tablets, 10 Milliequivalents and 20 Milliequivalents, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 88Number: 148Pages: 51324 - 51325
Pages: 51324, 51325Docket number: [Docket No. FDA-2023-P-2339]
FR document: [FR Doc. 2023-16537 Filed 8-2-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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That K-TAB (Potassium Chloride) Extended-Release Tablets, 10 Milliequivalents and 20 Milliequivalents, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.
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that K-TAB (potassium chloride) extended-release tablets, 10 milliequivalents and 20 milliequivalents, were not withdrawn from sale for reasons of safety or effectiveness.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, veniqua.stewart@fda.hhs.gov.
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 (§?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 §?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.
[top] Accordingly, the Agency will continue to list K-TAB (potassium
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