Notice2025-16349
Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
August 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 90 Issue 163 (Tuesday, August 26, 2025)</title>
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[Federal Register Volume 90, Number 163 (Tuesday, August 26, 2025)]
[Notices]
[Pages 41572-41573]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16349]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0060]
Determination That Four Heparin Sodium In Sodium Chloride In
Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn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 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN
PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100
milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL;
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC
CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN
SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(heparin sodium) injectable, 5,000 units/100 mL under new drug
application (NDA) 019802 were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) that refer to these products
if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Madeleine Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 240-
863-8976, <a href="/cdn-cgi/l/email-protection#7914181d1c151c10171c571e1018080c10170d16391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="bfd2dedbdad3dad6d1da91d8d6dececad6d1cbd0ffd9dbde91d7d7cc91d8d0c9">[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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC
CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN
SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
(heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000
UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium)
injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable,
5,000 units/100 mL are the subject of NDA 019802, held by B. Braun
Medical Inc., and initially approved on July 20, 1992. These drug
products are indicated for anticoagulant therapy in prophylaxis and
treatment of venous thrombosis and its extension; for prophylaxis and
treatment of pulmonary embolism; in atrial fibrillation with
embolization; for diagnosis and treatment of acute and chronic
consumptive coagulopathies (disseminated intravascular coagulation);
for prevention of clotting in arterial and heart surgery; and in
prophylaxis and treatment of peripheral arterial embolism.
The HEPARIN SODIUM IN SODIUM CHLORIDE IN PLASTIC CONTAINER (heparin
sodium) drug products listed in this document are currently listed in
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 019802, effective July 21, 2017.
B. Braun Medical Inc. submitted a citizen petition dated January
10, 2022 (Docket No. FDA-2022-P-0060), under 21 CFR 10.30, requesting
that the Agency determine whether the following drug products were
withdrawn from sale for reasons of safety or effectiveness:
<bullet> HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN
PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL;
<bullet> HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN
PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL;
<bullet> HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN
PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and
<bullet> HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL.
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 the four HEPARIN
[[Page 41573]]
SODIUM IN SODIUM CHLORIDE IN PLASTIC CONTAINER (heparin sodium) drug
products listed in this document were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that these drug products were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal from sale of the four
HEPARIN SODIUM IN SODIUM CHLORIDE IN PLASTIC CONTAINER (heparin sodium)
drug products listed in this document. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list the four HEPARIN
SODIUM IN SODIUM CHLORIDE IN PLASTIC CONTAINER (heparin sodium) drug
products listed in this document 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 these drug products 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 these drug products should be revised to meet current standards,
the Agency will advise ANDA applicants to submit such labeling.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16349 Filed 8-25-25; 8:45 am]
BILLING CODE 4164-01-P
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