Determination That CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder Excipient-Free Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, and CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder With Sodium Chloride Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 70665-70666 [2023-22494]
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–P–1344 and FDA–
2023–P–2655]
Determination That CYTOXAN
(Cyclophosphamide) for Injection
(Sterile Dry Powder Excipient-Free
Formulation), 500 Milligrams/Vial, 1
Gram/Vial, and 2 Grams/Vial, and
CYTOXAN (Cyclophosphamide) for
Injection (Sterile Dry Powder With
Sodium Chloride Formulation), 500
Milligrams/Vial, 1 Gram/Vial, and 2
Grams/Vial, Were Not Withdrawn From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 the sterile dry powder
excipient-free formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
milligrams (mg)/vial, 1 gram (g)/vial,
and 2 g/vial, and the sterile dry powder
with sodium chloride formulation of
CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/
vial, were not withdrawn from sale for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 the sterile dry
powder excipient-free formulation or
the sterile dry powder with sodium
chloride formulation of these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
these formulations of CYTOXAN as long
as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Tereza Hess, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6221, Silver Spring,
MD 20993–0002, 202–768–5659,
Tereza.Hess@fda.hhs.gov.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
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: (1)
whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that
referred to the listed drug have been
approved and (2) 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.
CYTOXAN (cyclophosphamide) for
Injection (sterile dry powder with
sodium chloride formulation), with the
500 mg/vial, initially approved on May
4, 1964, the 1 g/vial, initially approved
on August 30, 1982, and the 2 g/vial,
initially approved on August 30, 1982,
are the subjects of NDA 012142, held by
Baxter Pharmaceuticals. Subsequently,
CYTOXAN (cyclophosphamide) for
Injection (lyophilized powder with
mannitol) was also approved under
NDA 012142, with the 500 mg/vial
approved on January 4, 1984; the 1 g/
vial approved on September 24, 1985;
and the 2 g/vial approved on December
10, 1985. On November 7, 2003, the
lyophilized powder with mannitol
formulation in 500 mg/vial, 1 g/vial, and
2 g/vial strengths was reformulated and
approved as a sterile dry powder
excipient-free formulation under
Supplement 107 to NDA 012142. On
March 31, 2012, the CYTOXAN
(cyclophosphamide) for Injection, sterile
dry powder with sodium chloride
formulation in 500 mg/vial, 1 g/vial, and
2 g/vial strengths was reformulated and
approved as a lyophilized powder with
mannitol formulation under
Supplement 113. CYTOXAN is
indicated for treatment of malignant
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
70665
lymphomas: Hodgkin’s disease,
lymphocytic lymphoma, mixed-cell
type lymphoma, histiocytic lymphoma,
Burkitt’s lymphoma, multiple myeloma,
leukemias, mycosis fungoides,
neuroblastoma, adenocarcinoma of the
ovary, retinoblastoma, breast carcinoma,
and minimal change nephrotic
syndrome in pediatric patients.
FDA previously determined that
certain CYTOXAN (cyclophosphamide)
for Injection formulations and strengths
were not discontinued from sale for
reasons of safety or effectiveness, but
these determinations did not address all
previously approved formulations and
strengths. In the Federal Register of
March 1, 2004 (69 FR 9630), FDA issued
a determination that CYTOXAN
(cyclophosphamide) for Injection (nonlyophilized formulation), 2 g/vial, was
not withdrawn from sale for reasons of
safety or effectiveness. In the Federal
Register of August 5, 2013 (78 FR
47321), FDA issued a determination that
CYTOXAN (cyclophosphamide) for
Injection (lyophilized formulations), 100
mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, and CYTOXAN
(cyclophosphamide) for Injection (nonlyophilized formulations), 100 mg/vial
and 200 mg/vial, were not withdrawn
from sale for reasons of safety or
effectiveness. Neither of the previous
Federal Register notices expressly
indicate that the determinations were
made for the sterile dry powder
excipient-free formulation of CYTOXAN
(cyclophosphamide) for Injection in the
500 mg/vial, 1 g/vial, and 2 g/vial
strengths or the sterile dry powder with
sodium chloride formulation of
CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/
vial.
The sterile dry powder excipient-free
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, and the
sterile dry powder with sodium chloride
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, are
discontinued.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated May
5, 2020 (Docket No. FDA–2020–P–
1344), under 21 CFR 10.30, requesting
that the Agency determine whether
discontinued formulations of all
strengths of CYTOXAN
(cyclophosphamide) for Injection
approved under NDA 012142, including
the sterile dry powder excipient-free
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, were
withdrawn from sale for reasons of
safety or effectiveness. Epic Pharma,
E:\FR\FM\12OCN1.SGM
12OCN1
ddrumheller on DSK120RN23PROD with NOTICES1
70666
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
LLC submitted a citizen petition dated
June 27, 2023 (Docket No. FDA–2023–
P–2655), also requesting that the Agency
determine whether the sterile dry
powder excipient-free formulation of
CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/
vial, were withdrawn from sale for
reasons of safety or effectiveness.
Although the citizen petitions did not
specifically address the sterile dry
powder with sodium chloride
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, this
formulation also has been discontinued.
We have also determined whether the
sterile dry powder with sodium chloride
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, was
withdrawn for safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CYTOXAN
(cyclophosphamide) for Injection
(sterile dry powder excipient-free
formulation), 500 mg/vial, 1 g/vial, and
2 g/vial, and CYTOXAN
(cyclophosphamide) for Injection
(sterile dry powder with sodium
chloride formulation), 500 mg/vial, 1 g/
vial, and 2 g/vial, were not withdrawn
for reasons of safety or effectiveness.
The petitioners have identified no data
or other information suggesting that the
sterile dry powder excipient-free
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, or the
sterile dry powder with sodium chloride
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of the sterile
dry powder excipient-free formulation
of CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/
vial, and the sterile dry powder with
sodium chloride formulation of
CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/
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 these drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency has
determined that the sterile dry powder
excipient-free formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
mg/vial, 1 g/vial, and 2 g/vial, and the
sterile dry powder with sodium chloride
formulation of CYTOXAN
(cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, drug
products have been discontinued from
marketing for reasons other than safety
or effectiveness. FDA will not begin
procedures to withdraw approval of
approved ANDAs that have the sterile
dry powder excipient-free formulation
or the sterile dry powder with sodium
chloride formulation. ANDAs that refer
to CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/
vial may 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 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22494 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2030]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Allegations of
Regulatory Misconduct Voluntarily
Submitted to the Center for Devices
and Radiological Health
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by November
13, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
control number for this information
collection is 0910–0769. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Allegations of Regulatory Misconduct
Voluntarily Submitted to the Center for
Devices and Radiological Health
OMB Control Number 0910–0769—
Extension
This information collection supports
the voluntary submission of allegations
of regulatory misconduct to FDA’s
Center for Devices and Radiological
Health (CDRH). An allegation of
regulatory misconduct is a claim that a
medical device manufacturer or
individuals marketing medical devices
or electronic products regulated by
CDRH may be doing so in a manner that
violates the law. Reporting these
allegations can help make FDA aware of
regulatory concerns it may not learn of
otherwise. This information can help
FDA identify the potential risks to
patients and determine whether further
investigation is warranted, as well as
any steps needed to address or correct
a potential violation. Anyone may file a
complaint reporting an allegation of
regulatory misconduct. FDA encourages
people submitting allegations to include
supporting information and contact
information in case additional
information is needed for FDA to
understand the allegation and act on the
report; however, you can choose to
submit a report anonymously. FDA will
not share your identity or contact
information with anyone outside FDA
unless required to do so by law,
regulation, or court order.
Allegations of regulatory misconduct
may include failure to register and list
a medical device, marketing uncleared
or unapproved products, failure to
follow quality system requirements, or
misleading promotion.
You can submit an allegation through
the Allegations of Regulatory
Misconduct Form (https://www.fda.gov/
medical-devices/reporting-allegationsregulatory-misconduct/allegationsregulatory-misconduct-form), by email,
or by regular mail.
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70665-70666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22494]
[[Page 70665]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-P-1344 and FDA-2023-P-2655]
Determination That CYTOXAN (Cyclophosphamide) for Injection
(Sterile Dry Powder Excipient-Free Formulation), 500 Milligrams/Vial, 1
Gram/Vial, and 2 Grams/Vial, and CYTOXAN (Cyclophosphamide) for
Injection (Sterile Dry Powder With Sodium Chloride Formulation), 500
Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, 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 the sterile dry powder excipient-free formulation of
CYTOXAN (cyclophosphamide) for Injection, 500 milligrams (mg)/vial, 1
gram (g)/vial, and 2 g/vial, and the sterile dry powder with sodium
chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500
mg/vial, 1 g/vial, and 2 g/vial, 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 the sterile dry powder excipient-
free formulation or the sterile dry powder with sodium chloride
formulation of these drug products, and it will allow FDA to continue
to approve ANDAs that refer to these formulations of CYTOXAN as long as
they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Tereza Hess, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 202-
768-5659, [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: (1) whenever a listed drug is voluntarily withdrawn
from sale and ANDAs that referred to the listed drug have been approved
and (2) 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.
CYTOXAN (cyclophosphamide) for Injection (sterile dry powder with
sodium chloride formulation), with the 500 mg/vial, initially approved
on May 4, 1964, the 1 g/vial, initially approved on August 30, 1982,
and the 2 g/vial, initially approved on August 30, 1982, are the
subjects of NDA 012142, held by Baxter Pharmaceuticals. Subsequently,
CYTOXAN (cyclophosphamide) for Injection (lyophilized powder with
mannitol) was also approved under NDA 012142, with the 500 mg/vial
approved on January 4, 1984; the 1 g/vial approved on September 24,
1985; and the 2 g/vial approved on December 10, 1985. On November 7,
2003, the lyophilized powder with mannitol formulation in 500 mg/vial,
1 g/vial, and 2 g/vial strengths was reformulated and approved as a
sterile dry powder excipient-free formulation under Supplement 107 to
NDA 012142. On March 31, 2012, the CYTOXAN (cyclophosphamide) for
Injection, sterile dry powder with sodium chloride formulation in 500
mg/vial, 1 g/vial, and 2 g/vial strengths was reformulated and approved
as a lyophilized powder with mannitol formulation under Supplement 113.
CYTOXAN is indicated for treatment of malignant lymphomas: Hodgkin's
disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic
lymphoma, Burkitt's lymphoma, multiple myeloma, leukemias, mycosis
fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma,
breast carcinoma, and minimal change nephrotic syndrome in pediatric
patients.
FDA previously determined that certain CYTOXAN (cyclophosphamide)
for Injection formulations and strengths were not discontinued from
sale for reasons of safety or effectiveness, but these determinations
did not address all previously approved formulations and strengths. In
the Federal Register of March 1, 2004 (69 FR 9630), FDA issued a
determination that CYTOXAN (cyclophosphamide) for Injection (non-
lyophilized formulation), 2 g/vial, was not withdrawn from sale for
reasons of safety or effectiveness. In the Federal Register of August
5, 2013 (78 FR 47321), FDA issued a determination that CYTOXAN
(cyclophosphamide) for Injection (lyophilized formulations), 100 mg/
vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial, and CYTOXAN
(cyclophosphamide) for Injection (non-lyophilized formulations), 100
mg/vial and 200 mg/vial, were not withdrawn from sale for reasons of
safety or effectiveness. Neither of the previous Federal Register
notices expressly indicate that the determinations were made for the
sterile dry powder excipient-free formulation of CYTOXAN
(cyclophosphamide) for Injection in the 500 mg/vial, 1 g/vial, and 2 g/
vial strengths or the sterile dry powder with sodium chloride
formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1
g/vial, and 2 g/vial.
The sterile dry powder excipient-free formulation of CYTOXAN
(cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial,
and the sterile dry powder with sodium chloride formulation of CYTOXAN
(cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial,
are discontinued.
Lachman Consultant Services, Inc., submitted a citizen petition
dated May 5, 2020 (Docket No. FDA-2020-P-1344), under 21 CFR 10.30,
requesting that the Agency determine whether discontinued formulations
of all strengths of CYTOXAN (cyclophosphamide) for Injection approved
under NDA 012142, including the sterile dry powder excipient-free
formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1
g/vial, and 2 g/vial, were withdrawn from sale for reasons of safety or
effectiveness. Epic Pharma,
[[Page 70666]]
LLC submitted a citizen petition dated June 27, 2023 (Docket No. FDA-
2023-P-2655), also requesting that the Agency determine whether the
sterile dry powder excipient-free formulation of CYTOXAN
(cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial,
were withdrawn from sale for reasons of safety or effectiveness.
Although the citizen petitions did not specifically address the sterile
dry powder with sodium chloride formulation of CYTOXAN
(cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial,
this formulation also has been discontinued. We have also determined
whether the sterile dry powder with sodium chloride formulation of
CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2
g/vial, was withdrawn for safety or effectiveness.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that CYTOXAN (cyclophosphamide) for
Injection (sterile dry powder excipient-free formulation), 500 mg/vial,
1 g/vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection
(sterile dry powder with sodium chloride formulation), 500 mg/vial, 1
g/vial, and 2 g/vial, were not withdrawn for reasons of safety or
effectiveness. The petitioners have identified no data or other
information suggesting that the sterile dry powder excipient-free
formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1
g/vial, and 2 g/vial, or the sterile dry powder with sodium chloride
formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1
g/vial, and 2 g/vial, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of the sterile dry powder excipient-free
formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1
g/vial, and 2 g/vial, and the sterile dry powder with sodium chloride
formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1
g/vial, and 2 g/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 these drug
products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency has determined that the sterile dry powder
excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection,
500 mg/vial, 1 g/vial, and 2 g/vial, and the sterile dry powder with
sodium chloride formulation of CYTOXAN (cyclophosphamide) for
Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, drug products have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that have the sterile dry powder excipient-free
formulation or the sterile dry powder with sodium chloride formulation.
ANDAs that refer to CYTOXAN (cyclophosphamide) for Injection, 500 mg/
vial, 1 g/vial, and 2 g/vial may 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 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22494 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
