[Federal Register Volume 89, Number 200 (Wednesday, October 16, 2024)]
[Notices]
[Pages 83504-83505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23811]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-P-4163]


Determination That NOXAFIL (Posaconazole) Delayed-Release 
Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has 
determined that NOXAFIL (posaconazole) delayed-release tablets, 100 
grams (g), was not withdrawn from sale for reasons of safety or 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: Awo Archampong-Gray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 83505]]

Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#27665048096655444f464a574849400a6055465e67414346094f4f5409404851"><span class="__cf_email__" data-cfemail="7f3e0810513e0d1c171e120f10111852380d1e063f191b1e5117170c51181009">[email 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.
    NOXAFIL (posaconazole) delayed-release tablets, 100 g, is the 
subject of NDA 205053, held by Merck Sharp & Dohme Corp., and initially 
approved on November 25, 2013. Noxafil delayed-release tablets are 
indicated for the treatment of invasive aspergillosis in adults and 
pediatric patients 13 years of age and older. In addition, NOXAFIL is 
indicated for the prophylaxis of invasive Aspergillus and Candida 
infections in patients who are at high risk of developing these 
infections due to being severely immunocompromised, such as 
hematopoietic stem cell transplant recipients with graft-versus-host 
disease or those with hematologic malignancies with prolonged 
neutropenia from chemotherapy as follows; for NOXAFIL delayed-release 
tablets: adults and pediatric patients 2 years of age and older who 
weigh greater than 40 kilograms.
    NOXAFIL (posaconazole) delayed-release tablets, 100 g, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Aizant Drug Research Solutions Private Limited, submitted a citizen 
petition dated September 2, 2024 (Docket No. FDA-2024-P-4163), and 
amended on September 4, 2024, under 21 CFR 10.30, requesting that the 
Agency determine whether NOXAFIL (posaconazole) delayed-release 
tablets, NDA 205053 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 NOXAFIL (posaconazole) delayed-release 
tablets, 100 g, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that NOXAFIL (posaconazole) delayed-release 
tablets, 100 g, was withdrawn for reasons of safety or effectiveness. 
We have carefully reviewed our files for records concerning the 
withdrawal of NOXAFIL (posaconazole) delayed-release tablets, 100 g, 
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 NOXAFIL 
(posaconazole) delayed-release tablets, 100 g, 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. 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: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-23811 Filed 10-15-24; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>