[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Page 81419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-4223]


Determination That BUPRENEX (Buprenorphine Hydrochloride) 
Injection, 0.3 Milligram/Milliliter, Was Not Withdrawn From Sale for 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, the Agency, or we) has 
determined that BUPRENEX (buprenorphine hydrochloride) Injection, 0.3 
milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons 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: Caitlin Callahan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6269, Silver Spring, MD 20993-0002, 301-
796-3600, [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.
    BUPRENEX (buprenorphine hydrochloride) Injection, 0.3 mg/mL, is the 
subject of NDA 018401, held by Indivior, Inc., and initially approved 
on December 29, 1981. BUPRENEX is indicated for the management of pain 
severe enough to require an opioid analgesic and for which alternate 
treatments are inadequate.
    BUPRENEX (buprenorphine hydrochloride) Injection, 0.3 mg/mL, is 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book. Odin Pharmaceuticals LLC submitted a citizen petition 
dated September 27, 2023 (Docket No. FDA-2023-P-4223), under 21 CFR 
10.30, requesting that the Agency determine whether BUPRENEX 
(buprenorphine hydrochloride) Injection, 0.3 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 BUPRENEX (buprenorphine hydrochloride) 
Injection, 0.3 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 BUPRENEX (buprenorphine 
hydrochloride) Injection, 0.3 mg/mL, 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 BUPRENEX 
(buprenorphine hydrochloride) Injection, 0.3 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. 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: November 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25857 Filed 11-21-23; 8:45 am]
BILLING CODE 4164-01-P