Notice2022-05324
Determination That MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
March 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn from sale for reasons of safety or effectiveness.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 Succimer Kit, Injectable, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 87 Issue 49 (Monday, March 14, 2022)</title>
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[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14272-14273]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05324]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0959]
Determination That MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, Was Not Withdrawn From Sale for Reasons of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, Agency, or we) has
determined that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer
Kit), Injectable, was not withdrawn from sale for reasons of safety or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 Succimer Kit,
Injectable, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Michelle Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240
402-0374, <a href="/cdn-cgi/l/email-protection#94d9fdf7fcf1f8f8f1bac3f1fdfaf1e6d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="327f5b515a575e5e571c65575b5c5740725456531c5a5a411c555d44">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit),
Injectable, is the subject of NDA N017944, held by GE Healthcare, and
initially approved on May 18, 1982. MPI DMSA KIDNEY REAGENT is
indicated to be used as an aid in the scintigraphic evaluation of renal
parenchymal disorders. MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, is currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
Hyman, Phelps, & McNamara, P.C. submitted a citizen petition dated
August 27, 2021 (Docket No. FDA-
[[Page 14273]]
2021-P-0959), under 21 CFR 10.30, requesting that the Agency determine
whether MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit),
Injectable, 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 MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, 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 MPI DMSA KIDNEY
REAGENT ((Technetium Tc-99m Succimer Kit), Injectable, 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 MPI DMSA KIDNEY
REAGENT ((Technetium Tc-99m Succimer Kit), Injectable, 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: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05324 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-P
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