Notice2025-14690
Determination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100 Milliliters, and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
August 4, 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 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 milliliters (mL); HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 mL; and HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 1,000 units/100 mL under new drug application (NDA) 019042 were not withdrawn from sale for reasons of safety or effectiveness.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 147 (Monday, August 4, 2025)</title>
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[Federal Register Volume 90, Number 147 (Monday, August 4, 2025)]
[Notices]
[Pages 36442-36443]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14690]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0477]
Determination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE
0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100
Milliliters, and Two Other Drug Products Were Not Withdrawn From Sale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 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100
milliliters (mL); HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 mL; and
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(heparin sodium) injectable, 1,000 units/100 mL under new drug
application (NDA) 019042 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#701d1114151c15191e155e1719110105191e041f301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="2a474b4e4f464f43444f044d434b5b5f43445e456a4c4e4b04424259044d455c">[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
[[Page 36443]]
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
an 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.
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER (heparin sodium) injectable, 200 units/100 mL; HEPARIN SODIUM
2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin
sodium) injectable, 200 units/100 mL; and HEPARIN SODIUM 5,000 UNITS IN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable,
1,000 units/100 mL, are the subject of NDA 019042, held by B. Braun
Medical Inc., and initially approved on March 29, 1985. These drug
products are indicated as an anticoagulant to maintain catheter
patency.
The HEPARIN SODIUM IN SODIUM CHLORIDE IN PLASTIC CONTAINER (heparin
sodium) products listed in this document are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book. In the
Federal Register of March 4, 2005 (70 FR 10651), FDA announced that it
was withdrawing approval of NDA 091042, effective April 4, 2005.
B. Braun Medical Inc. submitted a citizen petition dated February
17, 2025 (Docket No. FDA-2025-P-0477), 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:
[ssquf] HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 mL;
[ssquf] HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 mL; and
[ssquf] HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) injectable, 1,000 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 HEPARIN SODIUM IN SODIUM CHLORIDE 0.9% IN
PLASTIC CONTAINER (heparin sodium) 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 HEPARIN SODIUM IN SODIUM
CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) 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 these drug products were withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the HEPARIN SODIUM IN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) 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.
Dated: July 30, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14690 Filed 8-1-25; 8:45 am]
BILLING CODE 4164-01-P
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