Document ID: FDA-2019-P-4523-0004
Agency: fda
Document Type: Notice
Title: Determination That Potassium Chloride in 5% Dextrose and 0.225%
Sodium Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15
Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40
Milliequivalents, in Plastic Containers, Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
Posted Date: 2020-03-17T04:00Z

[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15194-15195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05442]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-4523]

Determination That Potassium Chloride in 5% Dextrose and 0.225% 
Sodium Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15 
Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40 
Milliequivalents, in Plastic Containers, Were Not Withdrawn From Sale 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 the potassium chloride drug products listed in this 
notice were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) that refer to these drug products, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977, 
Linda.Jong@fda.hhs.gov.

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.
    The drug products listed in table 1 of this notice are no longer 
being marketed. All the products listed in table 1 are the subject of 
NDA 018365, held by ICU Medical, Inc., and initially approved on May 
29, 1980. The products are indicated in patients requiring parenteral 
administration of potassium chloride with minimal carbohydrate calories 
and sodium chloride.

[[Page 15195]]

                                 Table 1
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             Drug               Dosage form/route         Strength
------------------------------------------------------------------------
Potassium Chloride (5           Injectable/        5 grams (g)/100
 milliequivalents (mEq)) in 5%   Injection.         milliliters (mL);
 dextrose and 0.225% sodium                         74.5 milligrams (mg)/
 chloride, in plastic                               100 mL; 225 mg/100
 container.                                         mL.
Potassium Chloride (5 mEq) in   Do...............  5 g/100 mL; 149 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
Potassium Chloride (10 mEq) in  Do...............  5 g/100 mL; 74.5 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
Potassium Chloride (10 mEq) in  Do...............  5 g/100 mL; 149 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
Potassium Chloride (15 mEq) in  Do...............  5 g/100 mL; 224 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
Potassium Chloride (20 mEq) in  Do...............  5 g/100 mL; 298 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
Potassium Chloride (30 mEq) in  Do...............  5 g/100 mL; 224 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
Potassium Chloride (40 mEq) in  Do...............  5 g/100 mL; 298 mg/
 5% dextrose and 0.225% sodium                      100 mL; 225 mg/100
 chloride, in plastic                               mL.
 container.
------------------------------------------------------------------------

    The products listed in table 1 are currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book. 
Fresenius Kabi USA, LLC, submitted a citizen petition dated September 
26, 2019 (Docket No. FDA-2019-P-4523), under 21 CFR 10.30, requesting 
that the Agency determine whether the products listed in table 1 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 the potassium chloride drug products listed in 
this notice were not withdrawn for reasons of safety or effectiveness. 
The petitioner has identified no data or other information suggesting 
that the potassium chloride drug products listed in this notice were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of the 
potassium chloride drug products listed in this notice 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 the potassium chloride drug products listed in 
this notice were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list the potassium 
chloride drug products listed in this notice, 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. 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: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05442 Filed 3-16-20; 8:45 am]
 BILLING CODE 4164-01-P