Notice2023-11157
Determination That Heparin Sodium Injection 5000 USP Units/Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
May 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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(FDA, Agency, or we) has determined that Heparin Sodium Injection 5000 USP Units (IU)/ Milliliters (mL) was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 88 Issue 101 (Thursday, May 25, 2023)</title>
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[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33892-33893]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Milliliters Was Not Withdrawn From Sale for Reasons of Safety or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Milliliters (mL) was not withdrawn from sale for reasons of safety or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, <a href="/cdn-cgi/l/email-protection#5b15323834373e75162e3e37373e291b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="5b15323834373e75162e3e37373e291b3d3f3a75333328753c342d">[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
[[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:
<bullet> Prophylaxis and treatment of venous thrombosis and
pulmonary embolism.
<bullet> 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.
<bullet> Atrial fibrillation with embolization.
<bullet> Treatment of acute and chronic consumptive coagulopathies
(disseminated intravascular coagulation).
<bullet> Prevention of clotting in arterial and cardiac surgery.
<bullet> Prophylaxis and treatment of peripheral arterial embolism.
<bullet> 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
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