[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2934-2935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-1982]


Determination That OFIRMEV (Acetaminophen) Injection, 1,000 
Milligrams/100 Milliliters (10 Milligrams/Milliliter), Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we)

[[Page 2935]]

has determined that OFIRMEV (acetaminophen) injection, 1,000 milligrams 
(mg)/100 milliliters (mL) (10 mg/mL), was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for acetaminophen 
injection, 1,000 mg/100 mL (10 mg/mL), if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1546, [email protected].

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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    OFIRMEV (acetaminophen) injection, 1,000 mg/100 mL (10 mg/mL), is 
the subject of NDA 022450, held by Mallinckrodt Hospital Products IP 
Ltd. (Mallinckrodt), and initially approved on November 2, 2010. 
OFIRMEV is indicated for management of mild to moderate pain in adult 
and pediatric patients 2 years and older, management of moderate to 
severe pain with adjunctive opioid analgesics in adult and pediatric 
patients 2 years and older, and reduction of fever in adult and 
pediatric patients.
    In a letter dated June 24, 2021, Mallinckrodt notified FDA that 
OFIRMEV (acetaminophen) injection, 1,000 mg/100 mL (10 mg/mL), was 
being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Nines Consult Pharma, LLC, submitted a citizen petition dated 
August 22, 2022 (Docket No. FDA-2022-P-1982), under 21 CFR 10.30, 
requesting that the Agency determine whether OFIRMEV (acetaminophen) 
injection, 1,000 mg/100 mL (10 mg/mL), 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 OFIRMEV (acetaminophen) injection, 1,000 mg/
100 mL (10 mg/mL), was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that this drug product was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of OFIRMEV (acetaminophen) injection, 
1,000 mg/100 mL (10 mg/mL), from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have reviewed the available evidence and determined 
that this drug product was not withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list OFIRMEV 
(acetaminophen) injection, 1,000 mg/100 mL (10 mg/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 OFIRMEV 
(acetaminophen) injection, 1,000 mg/100 mL (10 mg/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 this drug product should be revised to meet current standards, the 
Agency will advise ANDA applicants to submit such labeling.

    Dated: January 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00792 Filed 1-17-23; 8:45 am]
BILLING CODE 4164-01-P


