Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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 Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.

Full Text

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<title>Federal Register, Volume 91 Issue 164 (Wednesday, August 26, 2026)</title>
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[Federal Register Volume 91, Number 164 (Wednesday, August 26, 2026)]
[Notices]
[Pages 55102-55103]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-P-3104]


Determination That CABAZITAXEL (Cabazitaxel) Solution 
(Injection), 60 Milligrams/6 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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) has 
determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 
milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from 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 
Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), 
if all other legal and regulatory requirements are met.

[[Page 55103]]


FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455, 
<a href="/cdn-cgi/l/email-protection#bbf5d2c8d3da95e8d3dad3fbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="aae4c3d9c2cb84f9c2cbc2eacccecb84c2c2d984cdc5dc">[email&#160;protected]</span></a>.

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.
    CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/
mL), is the subject of NDA 207970, held by Actavis LLC, an indirect, 
wholly owned subsidiary of Teva Pharmaceuticals USA, Inc. (referred to 
as Actavis LLC), and initially approved on March 14, 2024. CABAZITAXEL 
(cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL) is indicated 
in combination with prednisone for the treatment of patients with 
metastatic castration-resistant prostate cancer previously treated with 
a docetaxel-containing treatment regime.
    In a letter dated September 6, 2024, Actavis LLC notified FDA that 
CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), 
was being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Steve Jensen of ProPharma submitted a citizen petition dated March 
24, 2026, (Docket No. FDA-2026-P-3104), under 21 CFR 10.30, requesting 
that the Agency determine whether CABAZITAXEL (cabazitaxel) solution 
(injection), 60 mg/6 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 CABAZITAXEL (cabazitaxel) solution 
(injection), 60 mg/6 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 CABAZITAXEL 
(cabazitaxel) solution (injection), 60 mg/6 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 CABAZITAXEL 
(cabazitaxel) solution (injection), 60 mg/6 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 this drug product 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.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17401 Filed 8-25-26; 8:45 am]
BILLING CODE 4164-01-P


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