Determination That TAXOTERE (Docetaxel) Injection, 40 Milligrams/Milliliter Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 72950 [2011-30472]
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Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Notices
[FR Doc. 2011–30450 Filed 11–25–11; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0488]
Determination That TAXOTERE
(Docetaxel) Injection, 40 Milligrams/
Milliliter Was Not Withdrawn From Sale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 TAXOTERE (docetaxel) Injection,
40 milligrams/milliliter (mg/mL), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for docetaxel
injection, 40 mg/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6320, Silver Spring,
MD 20993–0002, (301) 796–3472.
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
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:34 Nov 25, 2011
Jkt 226001
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.
TAXOTERE (docetaxel) Injection, 40
mg/mL is the subject of NDA 20–449,
held by Sanofi-aventis U.S., and
initially approved on May 14, 1996.
TAXOTERE is indicated for breast
cancer, non-small cell lung cancer,
hormone refractory prostate cancer,
gastric adenocarcinoma, and squamous
cell carcinoma of the head and neck
cancer as described in detail on the drug
product’s labeling.
TAXOTERE (docetaxel) Injection, 40
mg/mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Sandoz, Inc. (Sandoz), submitted a
citizen petition dated June 21, 2011
(Docket No. FDA–2011–P–0488), under
21 CFR 10.30, requesting that the
Agency determine whether TAXOTERE
(docetaxel) Injection, 40 mg/mL, was
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
TAXOTERE (docetaxel) Injection, 40
mg/mL was not withdrawn for reasons
of safety or effectiveness. The petitioner
Sandoz has identified no data or other
information suggesting that TAXOTERE
(docetaxel) Injection, 40 mg/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
TAXOTERE (docetaxel) Injection, 40
mg/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 TAXOTERE (docetaxel)
Injection, 40 mg/mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
‘‘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 TAXOTERE (docetaxel) Injection, 40
mg/mL, 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 this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30472 Filed 11–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0799]
Draft Guidance for Industry: Use of
Nucleic Acid Tests on Pooled and
Individual Samples From Donors of
Whole Blood and Blood Components,
Including Source Plasma, to Reduce
the Risk of Transmission of Hepatitis
B Virus
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Use of Nucleic
Acid Tests (NAT) on Pooled and
Individual Samples from Donors of
Whole Blood and Blood Components
(including Recovered Plasma, Source
Plasma and Source Leukocytes) to
Adequately and Appropriately Reduce
the Risk of Transmission of Hepatitis B
Virus (HBV), and Requalification of
Donors Who Test HBV NAT Positive,’’
dated November 2011. The draft
guidance document provides
recommendations on the use of FDAlicensed nucleic acid tests (NAT) to
screen blood donors for hepatitis B virus
(HBV) deoxyribonucleic acid (DNA) and
recommendations for product testing
and disposition, donor management,
methods for donor requalification, and
product labeling. In addition, the draft
guidance provides notification that FDA
considers the use of an FDA-licensed
HBV NAT to be necessary to reduce
adequately and appropriately the risk of
transmission of HBV. The guidance is
intended for blood establishments that
SUMMARY:
E:\FR\FM\28NON1.SGM
28NON1
]]>Agencies
[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Page 72950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0488]
Determination That TAXOTERE (Docetaxel) Injection, 40 Milligrams/
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
TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for docetaxel injection, 40 mg/mL, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, (301) 796-3472.
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.
TAXOTERE (docetaxel) Injection, 40 mg/mL is the subject of NDA 20-
449, held by Sanofi-aventis U.S., and initially approved on May 14,
1996. TAXOTERE is indicated for breast cancer, non-small cell lung
cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and
squamous cell carcinoma of the head and neck cancer as described in
detail on the drug product's labeling.
TAXOTERE (docetaxel) Injection, 40 mg/mL, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
Sandoz, Inc. (Sandoz), submitted a citizen petition dated June 21,
2011 (Docket No. FDA-2011-P-0488), under 21 CFR 10.30, requesting that
the Agency determine whether TAXOTERE (docetaxel) Injection, 40 mg/mL,
was 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 TAXOTERE (docetaxel) Injection, 40 mg/mL was not withdrawn
for reasons of safety or effectiveness. The petitioner Sandoz has
identified no data or other information suggesting that TAXOTERE
(docetaxel) Injection, 40 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of TAXOTERE (docetaxel) Injection, 40 mg/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 TAXOTERE (docetaxel)
Injection, 40 mg/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. ANDAs that
refer to TAXOTERE (docetaxel) Injection, 40 mg/mL, 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 this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30472 Filed 11-25-11; 8:45 am]
BILLING CODE 4160-01-P
