[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68909-68910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or 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base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for 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, [email protected].

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