Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 71578 [2023-22844]
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71578
Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices
Dated: October 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22843 Filed 10–16–23; 8:45 am]
BILLING CODE 4164–01–P
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Were Not Withdrawn From Sale for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.
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were not withdrawn from sale for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.
SUMMARY:
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, Veniqua.stewart@
fda.hhs.gov.
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).
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:02 Oct 16, 2023
Jkt 262001
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 (§ 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/m2; 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
§ 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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4067]
Diabetic Foot Infections: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Diabetic
Foot Infections: Developing Drugs for
Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the
SUMMARY:
E:\FR\FM\17OCN1.SGM
17OCN1
]]>Agencies
[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
