[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Pages 15248-15249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-5232]
Determination That ETHYOL (Amifostine) for Injection, 500
Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 15249]]
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) has
determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/
vial, was not withdrawn from sale for reasons of safety or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: Helen Ryan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-796-1328,
[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.
ETHYOL (amifostine) for injection, 500 mg/vial, is the subject of
NDA 020221, held by Cosette Pharmaceuticals, Inc., and initially
approved on December 8, 1995. ETHYOL is a cytoprotective agent
indicated for reduction of cumulative renal toxicity associated with
repeated administration of cisplatin in patients with advanced ovarian
cancer. ETHYOL is also indicated for reduction of the incidence of
moderate to severe xerostomia in patients undergoing post-operative
radiation treatment for head and neck cancer, where the radiation port
includes a substantial portion of the parotid glands.
ETHYOL (amifostine) for injection, 500 mg/vial, is currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
Seacross Pharma USA, Inc. submitted a citizen petition dated
November 5, 2024 (Docket No. FDA-2024-P-5232), under 21 CFR 10.30,
requesting that the Agency determine whether ETHYOL (amifostine) for
injection, 500 mg/vial, 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 ETHYOL (amifostine) for injection, 500 mg/
vial, 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 ETHYOL (amifostine) for injection, 500 mg/vial, 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 ETHYOL (amifostine)
for injection, 500 mg/vial, 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: March 31, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06044 Filed 4-8-25; 8:45 am]
BILLING CODE 4164-01-P