[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30851-30852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12351]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1516]


Determination That SODIUM PERTECHNETATE TC-99M (Technetium Tc-99m 
Sodium Pertechnetate) Injection, Oral, 2 to 100 Millicuries per 
Milliliter and 10 to 60 Millicuries per Milliliter, Were Not Withdrawn 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) has determined that 
SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate) 
Injection, Oral, 2 to 100 millicuries per milliliter (mCi/mL) and 10 to 
60 mCi/mL, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for technetium Tc-99m sodium 
pertechnetate, injection, oral, 2 to 100 mCi/mL and 10 to 60 mCi/mL, 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. 6228, Silver Spring, MD 20993-0002, 240-402-4191.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 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 PERTECHNETATE TC-99M (technetium Tc-99m sodium 
pertechnetate) Injection, Oral, 2 to 100 mCi/mL, is the subject of NDA 
17-471, held by GE Healthcare. SODIUM PERTECHNETATE TC-99M (technetium 
Tc-99m sodium pertechnetate) Injection, Oral, 10 to 60 mCi/mL, is the 
subject of NDA 17-725, held by Mallinckrodt Pharmaceuticals. The most 
recent labeling indicates that SODIUM PERTECHNETATE TC-99M is used in 
adults as an agent for thyroid imaging, salivary gland imaging, urinary 
bladder imaging (direct isotopic cystography) for the detection of 
vesicoureteral reflux, and nasolacrimal drainage system imaging 
(dacryoscintigraphy). The most recent labeling also indicates that 
SODIUM PERTECHNETATE TC-99M is used in children as an agent for thyroid 
imaging and urinary bladder imaging (direct isotopic cystography) for 
the detection of vesicoureteral reflux.
    In a letter dated April 15, 2004, Amersham Health, the former 
holder of NDA 17-471, notified FDA that SODIUM PERTECHNETATE TC-99M 
(technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 mCi/
mL, was being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book. In the 
Federal Register of March 4, 2005 (70 FR 10651), FDA announced that it 
was withdrawing approval of NDA 17-471. In a letter dated October 23, 
2006, Mallinckrodt Pharmaceuticals, the holder of NDA 17-725, notified 
FDA that SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium 
pertechnetate) Injection, Oral, 10 to 60 mCi/mL, was being 
discontinued, and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book. In the Federal Register of 
November 7, 2007 (72 FR 62858), FDA announced that it was withdrawing 
approval of NDA 17-725.
    Spectron mrc, LLC, submitted a citizen petition dated November 19, 
2013 (Docket No. FDA-2013-P-1516), under 21 CFR 10.30, requesting that 
the Agency determine whether SODIUM PERTECHNETATE TC-99M (technetium 
Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 mCi/mL and 10 to 
60 mCi/mL, 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 SODIUM PERTECHNETATE TC-99M (technetium Tc-99m 
sodium pertechnetate) Injection, Oral, 2 to 100 mCi/mL and 10 to 60 
mCi/mL, were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate) 
Injection, Oral, 2 to 100 mCi/mL and 10-60 mCi/mL, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of SODIUM PERTECHNETATE TC-
99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 
mCi/mL and 10 to 60 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 
these products were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list SODIUM PERTECHNETATE 
TC-99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 
100 mCi/mL and 10 to 60 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 PERTECHNETATE TC-99M 
(technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 mCi/
mL and 10 to 60 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

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to meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12351 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P