[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Page 56635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-1549]


Determination That BORTEZOMIB (Bortezomib) Solution, 2.5 
Milligrams/Milliliter and 3.5 Milligrams/1.4 Milliliter (2.5 
Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of 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) has 
determined that BORTEZOMIB (bortezomib) solution, 2.5 milligrams (mg)/
milliliter (mL) and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn from 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 
BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 mg/
mL), if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6213, 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.
    BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 
mg/mL), is the subject of NDA 215441, held by Accord Healthcare Inc., 
and initially approved on July 26, 2022. BORTEZOMIB is indicated for 
the treatment of adult patients with multiple myeloma or mantle cell 
lymphoma.
    In a letter dated February 8, 2023, Accord Healthcare Inc. notified 
FDA that BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL 
(2.5 mg/mL), was being discontinued, and FDA moved the drug product to 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Qilu Pharmaceutical (Hainan) Co., Ltd. submitted a citizen petition 
dated April 19, 2023 (Docket No. FDA-2023-P-1549), under 21 CFR 10.30, 
requesting that the Agency determine whether BORTEZOMIB (bortezomib) 
solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 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 BORTEZOMIB (bortezomib) solution, 2.5 mg/mL 
and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that BORTEZOMIB (bortezomib) solution, 2.5 mg/mL 
and 3.5 mg/1.4 mL (2.5 mg/mL), was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of BORTEZOMIB (bortezomib) solution, 2.5 mg/
mL and 3.5 mg/1.4 mL (2.5 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 BORTEZOMIB 
(bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 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 these drug products 
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 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17746 Filed 8-17-23; 8:45 am]
BILLING CODE 4164-01-P