Determination That NOVANTRONE (Mitoxantrone Hydrochloride) Injection, Equivalent to 25 Milligrams Base/12.5 Milliliter and Equivalent to 30 Milligrams Base/15 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 20685-20686 [2011-8819]
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<![CDATA[
20685
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents 4
21 CFR Section/FDA Form No.
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in Hours)
Total hours
558.5(i) .............................................................................
514.1(b)(8) and 514.8(c)(1) 3 ...........................................
FDA Form 356V ...............................................................
154
154
154
.01
.21
5.1
1.54
32.34
785.4
5
90
5
8
2,911
3,927
Total ..........................................................................
........................
..........................
..........................
........................
33,319
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Evidence—Because 21 CFR 514.4 only defines substantial evidence, it should not be viewed as creating additional collection bur-
2 Substantial
den.
3 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall preapproval safety evaluation.
4 Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 154 annual respondents
during the 5 fiscal years, from October 1, 2005, through September 30, 2010, on which these estimates were made. We use this estimate consistently throughout the table and calculate the ‘‘annual frequency per respondent’’ by dividing the total annual responses by the number of
respondents.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8906 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0485]
Determination That NOVANTRONE
(Mitoxantrone Hydrochloride) Injection,
Equivalent to 25 Milligrams Base/12.5
Milliliter and Equivalent to 30
Milligrams Base/15 Milliliter, 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Withdrawn From Sale for Reasons of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 NOVANTRONE (mitoxantrone
hydrochloride) Injection, equivalent to
(EQ) 25 milligrams (mg) base/12.5
milliliters (mL) and EQ 30 mg base/15
mL, was 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 this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Rachel Bressler, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6302,
Silver Spring, MD 20993–0002, 301–
796–4288.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NOVANTRONE (mitoxantrone
hydrochloride) Injection, EQ 25 mg
base/12.5 mL and EQ 30 mg base/15 mL,
is the subject of NDA 19–297, held by
EMD Serono, and initially approved on
December 23, 1987. NOVANTRONE is
indicated for reducing neurologic
disability and/or the frequency of
clinical relapses in patients with
secondary (chronic) progressive,
progressive relapsing, or worsening
relapsing-remitting multiple sclerosis
(i.e., patients whose neurologic status is
significantly abnormal between
relapses). NOVANTRONE
(mitoxantrone hydrochloride) Injection,
EQ 25 mg base/12.5 mL and EQ 30 mg
base/15 mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. There are
approved ANDAs for NOVANTRONE
(mitoxantrone hydrochloride) Injection,
EQ 25 mg base/12.5 mL and EQ 30 mg
base/15 mL; these ANDAs are listed in
the Orange Book.
Apotex, Inc., submitted a citizen
petition dated September 3, 2008
(Docket No. FDA–2008–P–0485), under
21 CFR 10.30, requesting that the
Agency determine whether
NOVANTRONE (mitoxantrone
hydrochloride) Injection, 25 mg/12.5 mL
and 30 mg/15 mL, was withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
NOVANTRONE (mitoxantrone
hydrochloride) Injection, EQ 25 mg
base/12.5 mL and EQ 30 mg base/15 mL,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that NOVANTRONE
E:\FR\FM\13APN1.SGM
13APN1
20686
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
(mitoxantrone hydrochloride) Injection,
EQ 25 mg base/12.5 mL and EQ 30 mg
base/15 mL, was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
NOVANTRONE (mitoxantrone
hydrochloride) Injection, EQ 25 mg
base/12.5 mL and EQ 30 mg base/15 mL,
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 this product
was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NOVANTRONE
(mitoxantrone hydrochloride) Injection,
EQ 25 mg base/12.5 mL and EQ 30 mg
base/15 mL, 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 NOVANTRONE Injection. Additional
ANDAs for mitoxantrone hydrochloride
injection, EQ 25 mg base/12.5 mL and
EQ 30 mg base/15 mL, 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 this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8819 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0164]
Draft Guidance for Industry on Safety
Labeling Changes; Implementation of
the Federal Food, Drug, and Cosmetic
Act; Availability
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Safety Labeling
Changes—Implementation of Section
SUMMARY:
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
505(o)(4) of the Federal Food, Drug, and
Cosmetic Act.’’ The Food and Drug
Administration Amendments Act of
2007 (FDAAA) added new provisions to
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) authorizing FDA to
require certain drug and biological
product application holders to make
safety related labeling changes based
upon new safety information that
becomes available after the drug or
biological product is approved under
the FD&C Act or the Public Health
Service Act (the PHS Act). This draft
guidance provides information on the
implementation of the new provisions,
including a description of the types of
safety labeling changes that ordinarily
might be required under the new
legislation, how FDA plans to determine
what constitutes new safety
information, the procedures involved in
requiring safety labeling changes, and
enforcement of the requirements for
safety labeling changes.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 12, 2011.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. Send
one self-addressed adhesive label to
assist the office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Kristen Everett, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
796–5400, or Stephen Ripley, Center for
Biologics Evaluation and Research
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448, 301–827–
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act.’’ In the past, FDA has requested that
holders of applications for approved
products make labeling changes related
to safety after approval to address
serious risks. FDA learned of the
potential for such serious risks from a
variety of sources. In most cases,
application holders responded to these
requests by negotiating appropriate
language with FDA staff to address the
concerns, and then submitting a
supplement or amended supplement to
obtain approval of the change.
Negotiations were often protracted, and
FDA had few tools available at its
disposal to end negotiations and require
the changes. Congress recognized the
limitations of FDA’s authority in this
area and, in FDAAA, gave FDA new
authority to require safety labeling
changes in certain circumstances.
Title IX, section 901 of FDAAA (Pub.
L. 110–85) amended the FD&C Act by
adding new section 505(o)(4) (21 U.S.C.
355(o)(4)). Section 505(o)(4) authorizes
FDA to require, and if necessary, order
labeling changes if FDA becomes aware
of new safety information that FDA
believes should be included in the
labeling of certain prescription drug and
biological products approved under
section 505 of the FD&C Act or section
351 of the PHS Act (42 U.S.C. 262).
Specifically, section 505(o)(4) of the
FD&C Act applies to prescription drug
products with an approved new drug
application (NDA) under section 505(b)
of the FD&C Act, biological products
with an approved biologics license
application (BLA) under section 351 of
the PHS Act, or prescription drug
products with an approved abbreviated
new drug application (ANDA) under
section 505(j) of the FD&C Act if the
reference listed drug (RLD) with an
approved NDA is not currently
marketed. FDAAA imposes timeframes
for application holders to submit and
FDA staff to review such changes, and
gives FDA new enforcement tools to
bring about timely and appropriate
labeling changes. This draft guidance
provides information on the
implementation of the new provisions,
including a description of the types of
safety labeling changes that ordinarily
E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20685-20686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8819]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0485]
Determination That NOVANTRONE (Mitoxantrone Hydrochloride)
Injection, Equivalent to 25 Milligrams Base/12.5 Milliliter and
Equivalent to 30 Milligrams Base/15 Milliliter, 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
NOVANTRONE (mitoxantrone hydrochloride) Injection, equivalent to (EQ)
25 milligrams (mg) base/12.5 milliliters (mL) and EQ 30 mg base/15 mL,
was 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
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Rachel Bressler, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6302, Silver Spring, MD 20993-0002, 301-
796-4288.
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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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.
NOVANTRONE (mitoxantrone hydrochloride) Injection, EQ 25 mg base/
12.5 mL and EQ 30 mg base/15 mL, is the subject of NDA 19-297, held by
EMD Serono, and initially approved on December 23, 1987. NOVANTRONE is
indicated for reducing neurologic disability and/or the frequency of
clinical relapses in patients with secondary (chronic) progressive,
progressive relapsing, or worsening relapsing-remitting multiple
sclerosis (i.e., patients whose neurologic status is significantly
abnormal between relapses). NOVANTRONE (mitoxantrone hydrochloride)
Injection, EQ 25 mg base/12.5 mL and EQ 30 mg base/15 mL, is currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book. There are approved ANDAs for NOVANTRONE (mitoxantrone
hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30 mg base/15
mL; these ANDAs are listed in the Orange Book.
Apotex, Inc., submitted a citizen petition dated September 3, 2008
(Docket No. FDA-2008-P-0485), under 21 CFR 10.30, requesting that the
Agency determine whether NOVANTRONE (mitoxantrone hydrochloride)
Injection, 25 mg/12.5 mL and 30 mg/15 mL, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that NOVANTRONE
(mitoxantrone hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30
mg base/15 mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that NOVANTRONE
[[Page 20686]]
(mitoxantrone hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30
mg base/15 mL, was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of NOVANTRONE (mitoxantrone hydrochloride) Injection, EQ 25 mg base/
12.5 mL and EQ 30 mg base/15 mL, 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
this product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list NOVANTRONE
(mitoxantrone hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30
mg base/15 mL, 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
NOVANTRONE Injection. Additional ANDAs for mitoxantrone hydrochloride
injection, EQ 25 mg base/12.5 mL and EQ 30 mg base/15 mL, 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 this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8819 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P
