[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25493-25494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Milligram Copper/Milliliter, Was Not Withdrawn From Sale for Reasons of 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milligram (mg) copper/milliliter (mL), was not withdrawn from sale for 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, [email protected].

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