Notice2022-09238
Determination That Cupric Sulfate Injection, Equivalent to 0.4 Milligram Copper/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that Cupric Sulfate Injection, equivalent to (EQ) 0.4 milligram (mg) copper/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 Cupric Sulfate Injection, EQ 0.4 mg copper/mL, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 87 Issue 83 (Friday, April 29, 2022)</title>
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[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25493-25494]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09238]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-1188]
Determination That Cupric Sulfate Injection, Equivalent to 0.4
Milligram Copper/Milliliter, Was Not Withdrawn From Sale for Reasons of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 or Agency) has
determined that Cupric Sulfate Injection, equivalent to (EQ) 0.4
milligram (mg) copper/milliliter (mL), was not withdrawn from sale for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 Cupric Sulfate
Injection, EQ 0.4 mg copper/mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 240-
825-9944, <a href="/cdn-cgi/l/email-protection#1c577d7968737f747532537779717b7e735c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="e9a2888c9d868a8180c7a6828c848e8b86a98f8d88c781819ac78e869f">[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.
Cupric Sulfate Injection, EQ 0.4 mg copper/mL, is the subject of
NDA 019350, held by Abraxis Pharmaceutical Products, and initially
approved on May 5, 1987. Cupric Sulfate Injection is indicated for use
as a supplement to intravenous solutions given for total parenteral
nutrition, to prevent and treat copper deficiency.
In a letter dated April 17, 1995, Fujisawa USA, Inc. (the applicant
at that time), notified FDA that Cupric Sulfate Injection, EQ 0.4 mg
copper/mL, was being discontinued, and requested withdrawal of NDA
019350. FDA moved the drug product to the ``Discontinued Drug Product
List'' section of the Orange Book. In the Federal Register of June 21,
2017 (82 FR 28322), FDA announced that it was withdrawing approval of
NDA 019350, effective June 21, 2017.
Arent Fox LLP submitted a citizen petition dated November 2, 2021
(Docket No. FDA-2021-P-1188), under 21 CFR 10.30, requesting that the
Agency determine whether Cupric Sulfate Injection, EQ 0.4 mg copper/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 Cupric Sulfate Injection, EQ 0.4 mg copper/mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
Cupric Sulfate Injection, EQ 0.4 mg copper/mL, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of Cupric Sulfate
Injection, EQ 0.4 mg copper/mL, 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.
[[Page 25494]]
Accordingly, the Agency will continue to list Cupric Sulfate
Injection, EQ 0.4 mg copper/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 Cupric Sulfate Injection, EQ 0.4 mg
copper/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: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09238 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P
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