[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Pages 28112-28113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11021]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-2048]


Determination That MANGANESE SULFATE, Injectable, Equivalent 0.1 
Milligram Manganese/Milliliter, Was Not Withdrawn From Sale for Reasons 
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that MANGANESE SULFATE, injectable, equivalent (Eq) 0.1 
milligram (mg) manganese/milliliter (mL), was not withdrawn from sale 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 MANGANESE 
SULFATE, injectable, Eq 0.1 mg manganese/mL, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-
402-9674, Sungjoon.Chi@fda.hhs.gov.

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

[[Page 28113]]

listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an 
ANDA that does not refer to a listed drug.
    MANGANESE SULFATE, injectable, Eq 0.1 mg manganese/mL, is the 
subject of NDA 019228, held by Abraxis Pharmaceutical Products, and 
initially approved on May 5, 1987. MANGANESE SULFATE is indicated for 
use as a supplement to intravenous solutions given for total parenteral 
nutrition. Administration helps to maintain manganese serum levels and 
to prevent depletion of endogenous stores and subsequent deficiency 
symptoms.
    MANGANESE SULFATE, injectable, Eq 0.1 mg manganese/mL, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Fresenius Kabi USA, LLC, submitted a citizen petition dated October 
4, 2020 (Docket No. FDA-2020-P-2048), under 21 CFR 10.30, requesting 
that the Agency determine whether MANGANESE SULFATE, injectable, Eq 0.1 
mg manganese/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 MANGANESE SULFATE, injectable, Eq 0.1 mg 
manganese/mL, was not withdrawn for reasons of safety or effectiveness. 
The petitioner has identified no data or other information suggesting 
that MANGANESE SULFATE, injectable, Eq 0.1 mg manganese/mL, was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of MANGANESE 
SULFATE, injectable, Eq 0.1 mg manganese/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 MANGANESE SULFATE, 
injectable, Eq 0.1 mg manganese/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 MANGANESE SULFATE, injectable, Eq 
0.1 mg manganese/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 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11021 Filed 5-24-21; 8:45 am]
BILLING CODE 4164-01-P


