Determination That Heparin Sodium Injection 5000 USP Units/Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 33892-33893 [2023-11157]
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Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
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heterotopic ossification in adults and
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18:04 May 24, 2023
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children (females aged 8 years and
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Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–11164 Filed 5–24–23; 8:45 am]
BILLING CODE 4164–01–P
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Not Withdrawn From Sale for Reasons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.
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(mL) was not withdrawn from sale for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, Nicole.Mueller@fda.hhs.gov.
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
SUMMARY:
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25MYN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
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 (§ 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
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
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
§ 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1268]
Use of Whole Slide Imaging in
Nonclinical Toxicology Studies:
Questions and Answers; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
PO 00000
Frm 00034
Fmt 4703
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guidance for industry entitled ‘‘Use of
Whole Slide Imaging in Nonclinical
Toxicology Studies: Questions and
Answers.’’ This guidance represents
FDA’s current thinking on the use of
whole slide images during good
laboratory practice (GLP)-compliant
toxicology studies. Documentation
practices during generation, use, and
retention of whole slide images have not
been clearly defined and vary among
nonclinical testing facilities. This
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management, documentation, and use of
whole slide images in histopathology
assessment and/or pathology peer
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SUMMARY:
33893
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E:\FR\FM\25MYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
