Notice2024-19333
Determination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
August 28, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that FENTANYL CITRATE Injections, equivalent to 2.5 milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for FENTANYL CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 89 Issue 167 (Wednesday, August 28, 2024)</title>
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[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68909-68910]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19333]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-0805]
Determination That FENTANYL CITRATE Injections, Equivalent to 2.5
Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100
Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or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 FENTANYL CITRATE Injections, equivalent to 2.5
milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg
base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for FENTANYL
CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5
mg base/100 mL (EQ 0.05 mg base/mL), if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Swati Rawani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 240-
402-9917, <a href="/cdn-cgi/l/email-protection#d380a4b2a7bafd81b2a4b2bdba93b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="590a2e382d30770b382e383730193f3d387731312a773e362f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic 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 68910]]
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
FENTANYL CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/
mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), are the subject of
NDA 215870, held by Exela Pharma Sciences, LLC, and initially approved
on February 8, 2023. FENTANYL CITRATE is indicated in adult and
pediatric patients ages 2 years and older for use as an opioid
analgesic supplement in general anesthesia, for administration with a
neuroleptic for the induction of anesthesia and as an adjunct in the
maintenance of general anesthesia, and for use as an anesthetic agent
with oxygen in selected high-risk patients, such as those undergoing
open heart surgery or certain complicated neurological or orthopedic
procedures.
Exela Pharma Sciences, LLC, has never marketed FENTANYL Injections,
EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100mL (EQ
0.05 mg base/mL). In a letter dated May 5, 2023, Exela Pharma Sciences,
LLC, notified FDA that FENTANYL CITRATE Injections, EQ 2.5 mg base/50
mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL),
were being discontinued, and FDA moved these drug products to the
``Discontinued Drug Product List'' section of the Orange Book. In
previous instances (see, e.g., 72 FR 9763 (March 5, 2007) and 61 FR
25497 (May 21, 1996)), the Agency has determined that, for purposes of
Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
February 13, 2024 (Docket No. FDA-2024-P-0805), under 21 CFR 10.30,
requesting that the Agency determine whether FENTANYL CITRATE
Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/
100 mL (EQ 0.05 mg base/mL), were 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 FENTANYL CITRATE Injections, EQ 2.5 mg base/50
mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL),
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 of FENTANYL CITRATE Injections, EQ 2.5 mg
base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg
base/mL), from sale. We have reviewed the available evidence and
determined that these drug products were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list FENTANYL CITRATE
Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/
100 mL (EQ 0.05 mg base/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 FENTANYL CITRATE Injections, EQ 2.5
mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg
base/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 these drug products should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19333 Filed 8-27-24; 8:45 am]
BILLING CODE 4164-01-P
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