[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Page 71578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22844]


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

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Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale 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.

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

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4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of 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, [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.
    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