[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]
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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Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or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.
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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grams (g), was not withdrawn from sale for reasons of safety or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, [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.
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