Notice2023-22844
Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
October 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) has determined that ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 88 Issue 199 (Tuesday, October 17, 2023)</title>
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[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Page 71578]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22844]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-3682]
Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating
Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale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 or the Agency) has
determined that ZOFRAN ODT (ondansetron) orally disintegrating tablets,
4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of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 these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Veniqua Stewart, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3267, <a href="/cdn-cgi/l/email-protection#2c7a4942455d594d025f58495b4d5e586c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="cf99aaa1a6bebaaee1bcbbaab8aebdbb8fa9abaee1a7a7bce1a8a0b9">[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.
ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8
mg, are the subject of NDA 020781, held by Sandoz Inc., and initially
approved on January 27, 1999. ZOFRAN ODT is indicated for the
prevention of nausea and vomiting associated with: highly emetogenic
cancer chemotherapy, including cisplatin greater than or equal to 50
mg/m\2\; initial and repeat courses of moderately emetogenic cancer
chemotherapy; and radiotherapy in patients receiving either total body
irradiation, single high-dose fraction to the abdomen, or daily
fractions to the abdomen. ZOFRAN ODT is also indicated for the
prevention of postoperative nausea and/or vomiting.
ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8
mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Sun Pharmaceutical Industries Limited submitted a citizen petition
dated August 24, 2023 (Docket No. FDA-2023-P-3682), under 21 CFR 10.30,
requesting that the Agency determine whether ZOFRAN ODT (ondansetron)
orally disintegrating tablets, 4 mg and 8 mg, were 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 ZOFRAN ODT (ondansetron) orally disintegrating
tablets, 4 mg and 8 mg, were not withdrawn from sale for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg, were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg, 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 these drug products were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ZOFRAN ODT
(ondansetron) orally disintegrating tablets, 4 mg and 8 mg, 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 these drug products.
Additional ANDAs for these drug products 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 these
drug products should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22844 Filed 10-16-23; 8:45 am]
BILLING CODE 4164-01-P
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