83 FR 22079 - Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 92 (May 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 92 (May 11, 2018)
| Page Range | 22079-22080 | |
| FR Document | 2018-10099 |
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)] [Notices] [Pages 22079-22080] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10099] ----------------------------------------------------------------------- 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Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 millicuries (mCi)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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
![Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 22079
information about this topic, including Interested persons may observe the • Presentation of government-issued
panel materials, is available at http:// deliberations, but the Committee will photographic identification to the
www.cms.gov/medicare-coverage- not hear further comments during this Federal Protective Service or Guard
database/indexes/medcac-meetings- time except at the request of the Service personnel.
index.aspx?bc=BAAAAAAAAAAA&. chairperson. The Committee will also • Inspection of vehicle’s interior and
We will no longer be providing paper allow a 15-minute unscheduled open exterior (this includes engine and trunk
copies of the handouts for the meeting. public session for any attendee to inspection) at the entrance to the
Electronic copies of all the meeting address issues specific to the topics grounds. Parking permits and
materials will be on the CMS website no under consideration. At the conclusion instructions will be issued after the
later than 2 business days before the of the day, the members will vote and vehicle inspection.
meeting. We encourage the participation the Committee will make its • Inspection, via metal detector or
of organizations with expertise in recommendation(s) to CMS. other applicable means, of all persons
procedural volume requirements, III. Registration Instructions entering the building. We note that all
especially pertaining to SAVRs, TAVRs items brought into CMS, whether
and PCIs, for hospitals to begin and CMS’ Coverage and Analysis Group is personal or for the purpose of
maintain TAVR programs. This meeting coordinating meeting registration. While presentation or to support a
is open to the public. The Committee there is no registration fee, individuals presentation, are subject to inspection.
will hear oral presentations from the must register to attend. You may register We cannot assume responsibility for
public for approximately 45 minutes. online at http://www.cms.gov/apps/ coordinating the receipt, transfer,
Time allotted for each presentation may events/upcomingevents.asp?str transport, storage, set-up, safety, or
be limited. If the number of registrants OrderBy=1&type=3 or by phone by timely arrival of any personal
requesting to speak is greater than can contacting the person listed in the FOR belongings or items used for
FURTHER INFORMATION CONTACT section of presentation or to support a
be reasonably accommodated during the
scheduled open public hearing session, this notice by the deadline listed in the presentation.
DATES section of this notice. Please
we may conduct a lottery to determine Note: Individuals who are not registered in
the speakers for the scheduled open provide your full name (as it appears on
advance will not be permitted to enter the
public hearing session. The contact your state-issued driver’s license), building and will be unable to attend the
person will notify interested persons address, organization, telephone meeting. The public may not enter the
regarding their request to speak by June number(s), fax number, and email building earlier than 45 minutes prior to the
address. You will receive a registration convening of the meeting.
25, 2018. Your comments should focus
confirmation with instructions for your
on issues specific to the list of topics All visitors must be escorted in areas
arrival at the CMS complex or you will
that we have proposed to the other than the lower and first floor
be notified that the seating capacity has
Committee. The list of research topics to levels in the Central Building.
been reached.
be discussed at the meeting will be
available on the following website prior IV. Security, Building, and Parking V. Collection of Information
to the meeting: http://www.cms.gov/ Guidelines This document does not impose
medicare-coverage-database/indexes/ This meeting will be held in a federal information collection requirements,
medcac-meetings-index.aspx?bc= government building; therefore, federal that is, reporting, recordkeeping or
BAAAAAAAAAAA&. We require that security measures are applicable. The third-party disclosure requirements.
you declare at the meeting whether you Real ID Act, enacted in 2005, establishes Consequently, there is no need for
have any financial involvement with minimum standards for the issuance of review by the Office of Management and
manufacturers (or their competitors) of state-issued driver’s licenses and Budget under the authority of the
any items or services being discussed. identification (ID) cards. It prohibits Paperwork Reduction Act of 1995 (44
Speakers presenting at the MEDCAC Federal agencies from accepting an U.S.C. Chapter 35).
meeting should include a full disclosure official driver’s license or ID card from Authority: 5 U.S.C. App. 2, section 10(a).
slide as their second slide in their a state unless the Department of Dated: May 3, 2018.
presentation for financial interests (for Homeland Security determines that the
example, type of financial association— Kate Goodrich,
state meets these standards. Beginning
consultant, research support, advisory Director, Center for Clinical Standards and
October 2015, photo IDs (such as a valid
board, and an indication of level, such Quality, Chief Medical Officer, Centers for
driver’s license) issued by a state or Medicare & Medicaid Services.
as minor association <$10,000 or major territory not in compliance with the
association >$10,000) as well as [FR Doc. 2018–10120 Filed 5–10–18; 8:45 am]
Real ID Act will not be accepted as
intellectual conflicts of interest (for identification to enter Federal buildings. BILLING CODE 4120–01–P
example, involvement in a federal or Visitors from these states/territories will
nonfederal advisory committee that has need to provide alternative proof of
discussed the issue) that may pertain in DEPARTMENT OF HEALTH AND
identification (such as a valid passport) HUMAN SERVICES
any way to the subject of this meeting. to gain entrance into CMS buildings.
If you are representing an organization, The current list of states from which a Food and Drug Administration
we require that you also disclose Federal agency may accept driver’s
conflict of interest information for that licenses for an official purpose is found [Docket No. FDA–2017–P–5592]
organization. If you do not have a at http://www.dhs.gov/real-id-
sradovich on DSK3GMQ082PROD with NOTICES
PowerPoint presentation, you will need Determination That SODIUM IODIDE I
enforcement-brief. We recommend that 123 (Sodium Iodide I-123), Oral
to present the full disclosure confirmed registrants arrive reasonably
information requested previously at the Solution, 2 Millicuries/Milliliter, Was
early, but no earlier than 45 minutes Not Withdrawn From Sale for Reasons
beginning of your statement to the prior to the start of the meeting, to allow
Committee. of Safety or Effectiveness
additional time to clear security.
The Committee will deliberate openly Security measures include the AGENCY: Food and Drug Administration,
on the topics under consideration. following: HHS.
VerDate Sep<11>2014 19:21 May 10, 2018 Jkt 244001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\11MYN1.SGM 11MYN1](https://thefederalregister.org/doc/83_FR_22171/page/1.svg)
![22080 Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
ACTION: Notice. 314.161)). FDA may not approve an advise ANDA applicants to submit such
ANDA that does not refer to a listed labeling.
SUMMARY: The Food and Drug drug.
Administration (FDA or Agency) has Dated: May 7, 2018.
SODIUM IODIDE I 123 (sodium
determined that SODIUM IODIDE I 123 Leslie Kux,
iodide I-123), oral solution, 2 mCi/mL,
(sodium iodide I-123), oral solution, 2 is the subject of NDA 017630, held by Associate Commissioner for Policy.
millicuries (mCi)/milliliter (mL), was GE Healthcare, and initially approved [FR Doc. 2018–10099 Filed 5–10–18; 8:45 am]
not withdrawn from sale for reasons of on March 24, 1976. SODIUM IODIDE I BILLING CODE 4164–01–P
safety or effectiveness. This 123 is indicated for use in the
determination will allow FDA to evaluation of thyroid function or
approve abbreviated new drug morphology. DEPARTMENT OF HEALTH AND
applications (ANDAs) for sodium iodide SODIUM IODIDE I 123 (sodium HUMAN SERVICES
I 123, oral solution, 2 mCi/mL, if all iodide I-123), oral solution, 2 mCi/mL,
other legal and regulatory requirements is currently listed in the ‘‘Discontinued Food and Drug Administration
are met. Drug Product List’’ section of the Orange [Docket No. FDA–2018–N–1726]
FOR FURTHER INFORMATION CONTACT: Book.
Daniel Gottlieb, Center for Drug International Isotopes, Inc. submitted Circulatory System Devices Panel of
Evaluation and Research, Food and a citizen petition dated September 6, the Medical Devices Advisory
Drug Administration, 10903 New 2017 (Docket No. FDA–2017–P–5592), Committee; Notice of Meeting
Hampshire Ave., Bldg. 51, Rm. 6208, under 21 CFR 10.30, requesting that the
AGENCY: Food and Drug Administration,
Silver Spring, MD 20993–0002, 301– Agency determine whether SODIUM
HHS.
796–6650. IODIDE I 123 (sodium iodide I-123), oral
solution, 2 mCi/mL, was withdrawn ACTION: Notice.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price from sale for reasons of safety or SUMMARY: The Food and Drug
Competition and Patent Term effectiveness. Administration (FDA) announces a
Restoration Act of 1984 (Pub. L. 98–417) After considering the citizen petition forthcoming public advisory committee
(the 1984 amendments), which and reviewing Agency records and meeting of the Circulatory System
authorized the approval of duplicate based on the information we have at this Devices Panel of the Medical Devices
versions of drug products under an time, FDA has determined under Advisory Committee. The general
ANDA procedure. ANDA applicants § 314.161 that SODIUM IODIDE I 123 function of the committee is to provide
must, with certain exceptions, show that (sodium iodide I-123), oral solution, 2 advice and recommendations to the
the drug for which they are seeking mCi/mL, was not withdrawn from sale Agency on FDA’s regulatory issues. The
approval contains the same active for reasons of safety or effectiveness. meeting will be open to the public.
ingredient in the same strength and The petitioner has identified no data or
DATES: The meeting will be held on June
dosage form as the ‘‘listed drug,’’ which other information suggesting that
SODIUM IODIDE I 123 (sodium iodide 12, 2018, from 8 a.m. to 6 p.m.
is a version of the drug that was
I-123), oral solution, 2 mCi/mL, was ADDRESSES: Hilton Washington, DC
previously approved. ANDA applicants
withdrawn from sale for reasons of North/Gaithersburg, Salons A, B, C, and
do not have to repeat the extensive
safety or effectiveness. We have D, 620 Perry Pkwy., Gaithersburg, MD
clinical testing otherwise necessary to
gain approval of a new drug application carefully reviewed our files for records 20877. The hotel’s telephone number is
(NDA). concerning the withdrawal of SODIUM 301–977–8900. Answers to commonly
The 1984 amendments include what IODIDE I 123 (sodium iodide I-123), oral asked questions including information
is now section 505(j)(7) of the Federal solution, 2 mCi/mL, from sale. We have regarding special accommodations due
Food, Drug, and Cosmetic Act (21 U.S.C. also independently evaluated relevant to a disability, visitor parking, and
355(j)(7)), which requires FDA to literature and data for possible transportation may be accessed at:
publish a list of all approved drugs. postmarketing adverse events. We have https://www.fda.gov/
FDA publishes this list as part of the found no information that would AdvisoryCommittees/AboutAdvisory
‘‘Approved Drug Products With indicate that this drug product was Committees/ucm408555.htm.
Therapeutic Equivalence Evaluations,’’ withdrawn from sale for reasons of FOR FURTHER INFORMATION CONTACT:
which is known generally as the safety or effectiveness. Evella Washington, Center for Devices
‘‘Orange Book.’’ Under FDA regulations, Accordingly, the Agency will and Radiological Health, Food and Drug
drugs are removed from the list if the continue to list SODIUM IODIDE I 123 Administration, 10903 New Hampshire
Agency withdraws or suspends (sodium iodide I-123), oral solution, 2 Ave., Bldg. 66, Rm. G640, Silver Spring,
approval of the drug’s NDA or ANDA mCi/mL, in the ‘‘Discontinued Drug MD 20993–0002, Evella.Washington@
for reasons of safety or effectiveness or Product List’’ section of the Orange fda.hhs.gov; 301–796–6683, or FDA
if FDA determines that the listed drug Book. The ‘‘Discontinued Drug Product Advisory Committee Information Line,
was withdrawn from sale for reasons of List’’ delineates, among other items, 1–800–741–8138 (301–443–0572 in the
safety or effectiveness (§ 314.162 (21 drug products that have been Washington, DC area). A notice in the
CFR 314.162)). discontinued from marketing for reasons Federal Register about last minute
A person may petition the Agency to other than safety or effectiveness. modifications that impact a previously
determine, or the Agency may ANDAs that refer to SODIUM IODIDE I announced advisory committee meeting
determine on its own initiative, whether 123 (sodium iodide I-123), oral solution, cannot always be published quickly
sradovich on DSK3GMQ082PROD with NOTICES
a listed drug was withdrawn from sale 2 mCi/mL, may be approved by the enough to provide timely notice.
for reasons of safety or effectiveness. Agency as long as they meet all other Therefore, you should always check the
This determination may be made at any legal and regulatory requirements for Agency’s website at https://
time after the drug has been withdrawn the approval of ANDAs. If FDA www.fda.gov/AdvisoryCommittees/
from sale, but must be made prior to determines that labeling for this drug default.htm and scroll down to the
FDA’s approval of an ANDA that refers product should be revised to meet appropriate advisory committee meeting
to the listed drug (§ 314.161 (21 CFR current standards, the Agency will link, or call the advisory committee
VerDate Sep<11>2014 19:21 May 10, 2018 Jkt 244001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\11MYN1.SGM 11MYN1](https://thefederalregister.org/doc/83_FR_22171/page/2.svg)
Document Created: 2018-11-02 09:49:09
Document Modified: 2018-11-02 09:49:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 83 FR 22079 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR