Notice2025-09901
Determination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 2, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that EPINEPHRINE (epinephrine) solution, 1 milligram (mg)/ milliliter (mL), prefilled syringe for intravenous use, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 104 (Monday, June 2, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 104 (Monday, June 2, 2025)]
[Notices]
[Page 23341]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09901]
[[Page 23341]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-1021]
Determination That EPINEPHRINE (Epinephrine) Solution, 1
Milligram/Milliliter, Prefilled Syringe for Intravenous Use, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has
determined that EPINEPHRINE (epinephrine) solution, 1 milligram (mg)/
milliliter (mL), prefilled syringe for intravenous use, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#d88bacb9bba1f693b9b6bd98bebcb9f6b0b0abf6bfb7ae"><span class="__cf_email__" data-cfemail="9fccebfefce6b1d4fef1fadff9fbfeb1f7f7ecb1f8f0e9">[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.
EPINEPHRINE (epinephrine) solution, 1 mg/mL, prefilled syringe for
intravenous use, is the subject of NDA 205029, held by BPI Labs, LLC.
The NDA was initially approved on July 29, 2014. EPINEPHRINE is
indicated to increase mean arterial blood pressure in adult patients
with hypotension associated with septic shock.
In a letter dated May 29, 2024, BPI Labs, LLC notified FDA that
EPINEPHRINE (epinephrine) solution, 1 mg/mL, prefilled syringe for
intravenous use, was being discontinued, and FDA moved the drug product
to the ``Discontinued Drug Product List'' section of the Orange Book.
Alembic Pharmaceuticals Ltd. submitted a citizen petition dated
March 29, 2025 (Docket No. FDA-2025-P-1021), under 21 CFR 10.30,
requesting that the Agency determine whether EPINEPHRINE (epinephrine)
solution, 1 mg/mL, prefilled syringe for intravenous use, 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 EPINEPHRINE (epinephrine) solution, 1 mg/mL,
prefilled syringe for intravenous use, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that EPINEPHRINE (epinephrine) solution, 1 mg/
mL, prefilled syringe for intravenous use, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of EPINEPHRINE (epinephrine)
solution, 1 mg/mL, prefilled syringe for intravenous use, from sale. 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 EPINEPHRINE
(epinephrine) solution, 1 mg/mL, prefilled syringe for intravenous use,
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. FDA will not begin procedures to
withdraw approval of approved ANDAs that refer to this drug product.
Additional ANDAs for this drug product may also 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 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09901 Filed 5-30-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 2, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.