[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Notices]
[Pages 22059-22060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08615]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-2304]


Determination That Sodium Chloride 14.6% Solution for Injection, 
50 Milliequivalent/20 Milliliters, in Plastic Containers, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 Sodium Chloride 14.6% solution for injection, 50 
milliequivalent (mEq)/20 milliliters (mL), in plastic containers, was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for sodium chloride 14.6% solution for injection, 
50 mEq/20 mL, in plastic containers, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-402-4191, 
[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.
    Sodium chloride 14.6% solution for injection, 50 mEq/20 mL, in 
plastic containers, is the subject of NDA 18897, held by Hospira Inc., 
and initially approved on July 20, 1984. Sodium chloride 14.6% solution 
for injection is indicated for use as an electrolyte replenisher in 
parenteral fluid therapy.
    In a communication dated September 6, 2019, Hospira Inc. notified 
FDA that sodium chloride 14.6% solution for injection, 50 mEq/20 mL, in 
plastic containers, was being discontinued, and FDA moved the drug 
product to the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Fresenius Kabi USA, LLC submitted a citizen petition dated December 
16, 2020 (Docket No. FDA-2020-P-2304), under 21 CFR 10.30, requesting 
that the Agency determine whether sodium chloride 14.6% solution for 
injection, 50 mEq/20 mL, in plastic containers, 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 sodium chloride 14.6% solution for injection, 
50 mEq/20 mL, in plastic containers, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that sodium chloride 14.6% solution for 
injection, 50 mEq/20 mL, in plastic containers, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of sodium chloride 14.6% 
solution for injection, 50 mEq/20 mL, in plastic containers, 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 this drug product was not withdrawn from 
sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list sodium chloride 14.6% 
solution for injection, 50 mEq/20 mL, in plastic containers, 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

[[Page 22060]]

discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs that refer to sodium chloride 14.6% solution for 
injection, 50 mEq/20 mL, in plastic containers, 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: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08615 Filed 4-23-21; 8:45 am]
BILLING CODE 4164-01-P