[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22079-22080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-5592]


Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), 
Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale 
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

[[Page 22080]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral 
solution, 2 millicuries (mCi)/milliliter (mL), was not withdrawn from 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 iodide I 123, oral solution, 2 mCi/mL, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.

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 
(Sec.  314.162 (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 FDA's approval of 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 IODIDE I 123 (sodium iodide I-123), oral solution, 2 mCi/mL, 
is the subject of NDA 017630, held by GE Healthcare, and initially 
approved on March 24, 1976. SODIUM IODIDE I 123 is indicated for use in 
the evaluation of thyroid function or morphology.
    SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 mCi/mL, 
is currently listed in the ``Discontinued Drug Product List'' section 
of the Orange Book.
    International Isotopes, Inc. submitted a citizen petition dated 
September 6, 2017 (Docket No. FDA-2017-P-5592), under 21 CFR 10.30, 
requesting that the Agency determine whether SODIUM IODIDE I 123 
(sodium iodide I-123), oral solution, 2 mCi/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 IODIDE I 123 (sodium iodide I-123), 
oral solution, 2 mCi/mL, was not withdrawn from sale for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that SODIUM IODIDE I 123 (sodium iodide I-123), 
oral solution, 2 mCi/mL, was withdrawn from sale for reasons of safety 
or effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of SODIUM IODIDE I 123 (sodium iodide I-123), 
oral solution, 2 mCi/mL, 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 SODIUM IODIDE I 123 
(sodium iodide I-123), oral solution, 2 mCi/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 SODIUM IODIDE I 123 (sodium iodide 
I-123), oral solution, 2 mCi/mL, 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: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10099 Filed 5-10-18; 8:45 am]
BILLING CODE 4164-01-P