Determination That CYTOXAN (Cyclophosphamide) for Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 47321-47322 [2013-18731]
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Federal Register / Vol. 78, No. 150 / Monday, August 5, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0241]
Determination That CYTOXAN
(Cyclophosphamide) for Injection Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that CYTOXAN (cyclophosphamide) for
Injection (lyophilized formulations), 100
milligrams (mg)/vial, 200 mg/vial, 500
mg/vial, 1 gram (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vial, were not withdrawn from sale for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. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for these
products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Christine Kirk, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–2465.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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
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SUMMARY:
VerDate Mar<15>2010
19:07 Aug 02, 2013
Jkt 229001
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.
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, 100
mg/vial and 200 mg/vial, are the subject
of NDA 012142, held by Baxter
Healthcare, and initially approved on
November 16, 1959. CYTOXAN for
Injection is an alkylating drug product
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
ovary, retinoblastoma, breast carcinoma,
and minimal change nephrotic
syndrome in pediatric patients.
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, 100
mg/vial and 200 mg/vial, are currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Foley & Lardner LLP submitted a
citizen petition dated February 26, 2013
(Docket No. FDA–2013–P–0241), under
21 CFR 10.30, requesting that the
Agency determine whether CYTOXAN
(cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial,
200 mg/vial, 500 mg/vial, 1 g/vial, and
2 g/vial, were voluntarily withdrawn or
withheld from sale for reasons of safety
or effectiveness. Although the citizen
petition did not address the nonlyophilized 100 mg/vial and 200 mg/
vial formulations, those strengths have
also been discontinued. On our own
initiative, we have also determined
whether those strengths were
withdrawn for safety or effectiveness
reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
47321
time, FDA has determined under
§ 314.161 that CYTOXAN
(cyclophosphamide) for Injection
(lyophilized formulations), 100mg/vial,
200mg/vial, 500 mg/vial, 1 g/vial, and 2
g/vial, and CYTOXAN
(cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that CYTOXAN
(cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial,
200 mg/vial, 500 mg/vial, 1 g/vial, and
2 g/vial, or CYTOXAN
(cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
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, 100
mg/vial and 200 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 these products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list 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, 100
mg/vial and 200 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. ANDAs that refer
to CYTOXAN (cyclophosphamide) for
Injection (lyophilized formulations), 100
mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, or CYTOXAN
(cyclophosphamide) for Injection, 100
mg/vial and 200 mg/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.
E:\FR\FM\05AUN1.SGM
05AUN1
47322
Federal Register / Vol. 78, No. 150 / Monday, August 5, 2013 / Notices
Dated: July 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18731 Filed 8–2–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; Report of an
Altered System of Records
Health Resources and Services
Administration, Department of Health
and Human Services (HHS).
ACTION: Notice of an altered system of
records and deletion of a related system.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974
(5 U.S.C. 552a), the Health Resources
and Services Administration (HRSA) is
publishing notice of a proposal to alter
the system of records entitled and
numbered National Practitioner Data
Bank for Adverse Information on
Physicians and other Health Care
Practitioners (NPDB), #09–15–0054, to
include information covered under a
related system of records, the Healthcare
Integrity and Protection Data Bank
(HIPDB), SORN 09–90–0103, which is
being deleted. The NPDB SORN was last
published March 30, 2012 (77 FR
19295). The proposed alterations to the
NPDB SORN include revising the
Purpose section, expanding the
Categories of Individuals, Categories of
Records, and Record Sources Categories
sections, revising two existing routine
uses and adding one new routine use,
deleting three unnecessary routine uses,
and updating the Authority and Policies
and Practices sections.
DATES: HRSA filed an altered system
report with the Chair of the House
Committee on Government Reform and
Oversight, the Chair of the Senate
Committee on Homeland Security and
Governmental Affairs, and the
Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on July
17, 2013. To ensure all parties have
adequate time in which to comment, the
system alterations proposed in this
notice will become effective 30 days
from the publication of this notice in the
Federal Register or 40 days from the
date the altered system report was
submitted to OMB and Congress,
whichever is later, unless HRSA
receives comments that require
alterations to this notice. The HIPDB
SORN will be considered deleted when
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SUMMARY:
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19:07 Aug 02, 2013
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the system alterations proposed in this
notice are effective.
ADDRESSES: Please address comments to
Associate Administrator, Bureau of
Health Professions, Health Resources
and Services Administration, 5600
Fishers Lane, Room 9–05 Rockville,
Maryland 20857. Comments received
will be available for inspection at this
same address from 9:00 a.m. to 3:00
p.m. (Eastern Standard Time Zone),
Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Practitioner Data
Banks, Bureau of Health Professions,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 8–103, Rockville, Maryland
20857; Telephone: (301) 443–2300. This
is not a toll-free number.
SUPPLEMENTARY INFORMATION:
I. Merger of HIPDB Into NPDB
The NPDB and the HIPDB were
authorized by separate laws to improve
the quality of health care and to combat
fraud and abuse, respectively. Title IV of
the Health Care Quality Improvement
Act (Title IV) and Section 1921 of the
Social Security Act (Section 1921)
govern the NPDB. Section 1128E of the
Social Security Act (Section 1128E)
governs the HIPDB. There was overlap
between the two data banks following
implementation of Section 1921
legislation in March 2010. Section 1921
expanded the scope of the NPDB,
requiring each state to adopt a system of
reporting to the Secretary certain
adverse licensure actions taken against
health care practitioners and health care
entities by any authority of the state
responsible for the licensing of such
practitioners or entities. It also required
each state to report any negative action
or finding that a state licensing
authority, a peer review organization, or
a private accreditation entity has
finalized against a health care
practitioner or entity. Practically
speaking, Section 1921 resulted in,
among other consequences, including in
the NPDB the vast majority of
information contained in the HIPDB. On
March 23, 2010, the Affordable Care Act
was signed into law. Section 6403 of the
law called for the elimination of
duplication between the NPDB and the
HIPDB. Section 1921 and Section 1128E
statutory authorities were altered to
eliminate duplicative reporting
requirements.
The NPDB and HIPDB will merge to
form one data bank. The HIPDB will
cease operations following the merge,
but the underlying statutory authority
will remain intact and actions reported
under that authority will now be moved
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
to the NPDB. HRSA published a Final
Rule merging the two databank systems
on April 5, 2013 (78 FR 20473) that
went into effect on May 6, 2013.
II. Proposed Alterations to NPDB
The revised NPDB SORN that follows
includes these system alterations:
• revises the Purpose section to
reflect the addition of information
previously collected under the HIPDB
related to fraud and abuse, specifically
the inclusion of health care providers
and suppliers and collection of health
care related criminal convictions, civil
judgments, and other adjudicated
actions
• expands the Categories of
Individuals section to include health
care providers and health care suppliers
• expands the Categories of Records
section to include records of federal
licensure or certification actions, health
care related criminal convictions, health
care related civil judgments, and other
adjudicated actions or decisions. These
additional records resulted in one
revised and eleven new personally
identifiable information data elements
numbered 4 and 21–31, respectively.
• expands the ‘‘Records Sources
Categories’’ section to include federal
licensing and certification agencies,
federal and state prosecutors and
attorneys, health plans, federal
government agencies, and state law and
fraud enforcement agencies
• revises two routine uses (numbered
8 and 15) to reflect inclusion of health
care providers and suppliers and to
remove outdated references to only
Section 1921 information;
• adds one new routine use
(numbered 14) to allow disclosure of
certain information to health plans
• deletes three unnecessary routine
uses, pertaining to the Comptroller
General, the U.S. Attorney General, and
statistical information (numbered 7, 8
and 12 in the current version of the
SORN, published March 30, 2012)
• updates the Authority section to
cite Section 1128E of the Social Security
Act as amended by the Patient
Protection and Affordable Care Act of
2010
• updates the Policies and Procedures
section related to Safeguards,
specifically removing reference to only
Title IV reporting
III. Background on the Privacy Act
The Privacy Act (5 U.S.C. 552a)
governs the means by which the U.S.
Government collects, maintains, and
uses information about individuals in a
system of records. A ‘‘system of
records’’ is a group of any records under
the control of a federal agency from
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47321-47322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18731]
[[Page 47321]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0241]
Determination That CYTOXAN (Cyclophosphamide) for Injection Was
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) has determined that
CYTOXAN (cyclophosphamide) for Injection (lyophilized formulations),
100 milligrams (mg)/vial, 200 mg/vial, 500 mg/vial, 1 gram (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. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for these products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-2465.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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.
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, 100 mg/vial and
200 mg/vial, are the subject of NDA 012142, held by Baxter Healthcare,
and initially approved on November 16, 1959. CYTOXAN for Injection is
an alkylating drug product 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 ovary,
retinoblastoma, breast carcinoma, and minimal change nephrotic syndrome
in pediatric patients.
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, 100 mg/vial and
200 mg/vial, are currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
Foley & Lardner LLP submitted a citizen petition dated February 26,
2013 (Docket No. FDA-2013-P-0241), under 21 CFR 10.30, requesting that
the Agency determine whether CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, were voluntarily withdrawn or withheld from sale
for reasons of safety or effectiveness. Although the citizen petition
did not address the non-lyophilized 100 mg/vial and 200 mg/vial
formulations, those strengths have also been discontinued. On our own
initiative, we have also determined whether those strengths were
withdrawn for safety or effectiveness reasons.
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 CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100mg/vial, 200mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, or CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of 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, 100
mg/vial and 200 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
these products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list 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, 100 mg/vial and 200 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. ANDAs that refer to CYTOXAN
(cyclophosphamide) for Injection (lyophilized formulations), 100 mg/
vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial, or CYTOXAN
(cyclophosphamide) for Injection, 100 mg/vial and 200 mg/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.
[[Page 47322]]
Dated: July 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18731 Filed 8-2-13; 8:45 am]
BILLING CODE 4160-01-P
