[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Page 54579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-0438]


Determination That MICRO-K LS (Potassium Chloride) Extended-
Release Liquid Suspension, 20 Milliequivalents/Packet, Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 MICRO-K LS (potassium chloride) extended-release liquid 
suspension, 20 milliequivalents (mEq)/packet, was not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
MICRO-K LS (potassium chloride) extended-release liquid suspension, 20 
mEq/packet, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-
402-9674, [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.
    MICRO-K LS (potassium chloride) extended-release liquid suspension, 
20 mEq/packet, is the subject of NDA 019561, held by KV Pharmaceutical 
Co., and initially approved on August 26, 1988. MICRO-K LS is indicated 
for the treatment of patients with hypokalemia, with or without 
metabolic alkalosis; in digitalis intoxication; and in patients with 
hypokalemic familial periodic paralysis. MICRO-K LS is also indicated 
for the prevention of hypokalemia in patients who would be at 
particular risk if hypokalemia were to develop, e.g., digitalized 
patients or patients with significant cardiac arrhythmias, hepatic 
cirrhosis with ascites, states of aldosterone excess with normal renal 
function, potassium losing nephropathy, and certain diarrheal states.
    In a letter dated October 8, 2010, KV Pharmaceutical Co. notified 
FDA that MICRO-K LS (potassium chloride) extended-release liquid 
suspension, 20 mEq/packet, was being discontinued, and FDA moved the 
drug product to the ``Discontinued Drug Product List'' section of the 
Orange Book. In the Federal Register of June 8, 2011 (76 FR 33310), FDA 
announced that it was withdrawing approval of NDA 019561, effective 
July 8, 2011.
    Hyman, Phelps, and McNamara, P.C. submitted a citizen petition 
dated January 27, 2020 (Docket No. FDA-2020-P-0438), under 21 CFR 
10.30, requesting that the Agency determine whether MICRO-K LS 
(potassium chloride) extended-release liquid suspension, 20 mEq/packet, 
was 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 MICRO-K LS (potassium chloride) extended-
release liquid suspension, 20 mEq/packet, was not withdrawn for reasons 
of safety or effectiveness. The petitioner has identified no data or 
other information suggesting that MICRO-K LS (potassium chloride) 
extended-release liquid suspension, 20 mEq/packet, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of MICRO-K LS (potassium 
chloride) extended-release liquid suspension, 20 mEq/packet, from sale. 
We have also independently evaluated relevant literature and data for 
possible postmarketing adverse events. We have found no information 
that would indicate that this drug product was withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MICRO-K LS (potassium 
chloride) extended-release liquid suspension, 20 mEq/packet, 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 MICRO-K LS (potassium 
chloride) extended-release liquid suspension, 20 mEq/packet, 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: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19369 Filed 9-1-20; 8:45 am]
BILLING CODE 4164-01-P