[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89470-89471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1363]


Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER 
(Sodium Chloride), Injectable, 234 Milligrams/Milliliter, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 23.4% IN PLASTIC CONTAINER (sodium 
chloride), injectable, 234 milligrams (mg)/milliliter (mL), 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withdrawn from sale for reasons of safety or effectiveness.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, injectable, 234 mg/mL, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-8767.

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 23.4% IN PLASTIC CONTAINER (sodium chloride), 
injectable, 234 mg/mL, is the subject of NDA 019329, held by Abraxis 
Pharmaceutical Products, and initially approved on April 22, 1987. 
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER is indicated for use in 
patients who have special problems of sodium electrolyte intake or 
excretion, and for the treatment of sodium chloride and water 
deficiencies, which commonly occur in many diseases.
    In a letter dated January 18, 1996, the original NDA holder, 
Fujisawa USA, Inc., notified FDA that SODIUM CHLORIDE 23.4% IN PLASTIC 
CONTAINER (sodium chloride), injectable, 234 mg/mL, was being 
discontinued, and FDA moved the drug product to the ``Discontinued Drug

[[Page 89471]]

Product List'' section of the Orange Book.
    Gordon Johnston Regulatory Consultants, LLC, submitted a citizen 
petition dated May 25, 2016 (Docket No. FDA-2016-P-1363), under 21 CFR 
10.30, requesting that the Agency determine whether SODIUM CHLORIDE 
23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, 
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 23.4% IN PLASTIC CONTAINER 
(sodium chloride), injectable, 234 mg/mL, was not withdrawn for reasons 
of safety or effectiveness. The petitioner has identified no data or 
other information suggesting that SODIUM CHLORIDE 23.4% IN PLASTIC 
CONTAINER (sodium chloride), injectable, 234 mg/mL, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of SODIUM CHLORIDE 23.4% IN 
PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, 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 23.4% 
IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, 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 this drug product 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: December 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29674 Filed 12-9-16; 8:45 am]
 BILLING CODE 4164-01-P