[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33892-33893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-2952]


Determination That Heparin Sodium Injection 5000 USP Units/
Milliliters Was Not Withdrawn From Sale for Reasons of Safety or 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 Heparin Sodium Injection 5000 USP Units (IU)/
Milliliters (mL) was not withdrawn from sale for reasons of safety or 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 Heparin Sodium Injection 5000 USP IU/
mL, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [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

[[Page 33893]]

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FDA determines that the listed drug was withdrawn from sale for reasons 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 FDA's approval of 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.
    Heparin Sodium Injection 5000 USP IU/mL is the subject of NDA 
017029, held by Fresenius Kabi USA LLC, and initially approved on 
January 1, 1982. Heparin Sodium Injection is an anticoagulant indicated 
for:
     Prophylaxis and treatment of venous thrombosis and 
pulmonary embolism.
     Prevention of postoperative deep venous thrombosis and 
pulmonary embolism in patients undergoing major abdominothoracic 
surgery or who, for other reasons, are at risk of developing 
thromboembolic disease.
     Atrial fibrillation with embolization.
     Treatment of acute and chronic consumptive coagulopathies 
(disseminated intravascular coagulation).
     Prevention of clotting in arterial and cardiac surgery.
     Prophylaxis and treatment of peripheral arterial embolism.
     Use as an anticoagulant in blood transfusions, 
extracorporeal circulation, and dialysis procedures.
    In May 1991, FDA moved the Heparin Sodium Injection 5000 USP IU/mL 
to the ``Discontinued Drug Product List'' section of the Orange Book. 
BE Pharmaceuticals AG, submitted a citizen petition dated October 18, 
2022 (Docket No. FDA-2022-P-2952), under 21 CFR 10.30, requesting that 
the Agency determine whether Heparin Sodium Injection 5000 USP IU/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 Heparin Sodium Injection 5000 USP IU/mL was 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that Heparin 
Sodium Injection 5000 USP IU/mL was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of Heparin Sodium Injection 5000 USP IU/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.
    Accordingly, the Agency will continue to list Heparin Sodium 
Injection 5000 USP IU/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 Heparin Sodium Injection 5000 USP 
IU/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 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11157 Filed 5-24-23; 8:45 am]
BILLING CODE 4164-01-P