Determination That TEQUIN (Gatifloxacin) Injection, 10 Milligrams per Milliliter (200 Milligrams), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 5858-5859 [E6-1475]
Download as PDF
<![CDATA[
hsrobinson on PROD1PC70 with NOTICES
5858
Federal Register / Vol. 71, No. 23 / Friday, February 3, 2006 / Notices
mental health issues, in particular, was
found to be one of the weakest in the
CFSRs. Areas of interest for research
may examine CPS procedures for
identifying and responding to children’s
mental health issues as well as the
prevalence, type and severity of mental
health problems among children
identified in State child welfare
systems. In addition, findings from the
National Survey of Child and
Adolescent Well-Being (NSCAW) show
that high rates of mental health
problems among parents, coupled with
low rates of identification and referral,
is a serious issue. CB is interested in
research that examines mental health
services to parents.
Program Evaluation of Priority Area
Initiatives (or Evaluation of Programs
Addressing Administration Priorities):
The current Administration has focused
funding in areas of healthy marriage
promotion, fatherhood initiatives,
community and faith-based
organizations and youth development in
ensuring the healthy development of
children. CB is interested in research to
evaluate programs employing these
strategies to prevent child abuse and
neglect. Research topics may include
the evaluation of the effectiveness of
these programs as well as the
dissemination of promising practices.
Secondary Data Analysis: CB
encourages the utilization of existing
data sources particularly the use of
service data through the National Child
Abuse and Neglect Data System
(NCANDS). CB is interested in
secondary data analyses using NCANDS
focusing on service utilization,
recurrence and perpetrators.
Service utilization: While not all
States provide complete service data to
NCANDS, for those States that do
provide complete service data, the
following areas could be examined: The
services that are most often provided to
victims of maltreatment; differences in
service patterns that exist between
children who are first-time victims and
children who are repeat victims;
differences in service patterns that exist
between child victims who remain in
their homes and those who are removed;
and the variations in service patterns
within States according to county
characteristics.
Recurrence: To date, recurrence has
largely been examined for six-month
periods using NCANDS data. The Office
of the Assistant Secretary for Planning
and Evaluation undertook a longitudinal
analysis of NCANDS data examining
repeated CPS involvement. Using a
multiyear dataset of 1,396,998 children,
this research examined the proportion
of reported children who re-reported,
VerDate Aug<31>2005
15:00 Feb 02, 2006
Jkt 208001
the proportion of child victims who had
a recurrence of maltreatment and the
factors associated with these repeated
events. The findings showed that rereporting was relatively common—
about one-third of children had at least
one repeated report of maltreatment
within a five-year period. For the most
part, the same factors were related to
both re-reporting of all reported
children and recurrence among victims
of maltreatment. Findings were also
similar when analyses examined only
the presence of a single subsequent
event or the number and type of
multiple subsequent events. Both rereporting and recurrence occurred more
frequently among younger children. Rereporting and recurrence were more
likely to occur in a short time following
the initial maltreatment report, usually
within a few months. Most children
who experienced more than one rereport or re-victimization experienced
these events within a short time after
the initial event. Areas for further
research might examine: Factors that are
predictive of a second investigation;
report sources that are the most likely to
be associated with a second
investigation; services that decrease
subsequent investigation; and services
that decrease subsequent victimization.
Perpetrators: CB continues to be
interested in perpetrators, with the
notion that understanding who this
group is and what their characteristics
are, can help to inform more effective
intervention and prevention efforts. The
Office of the Assistant Secretary for
Planning and Evaluation undertook an
analysis of NCANDS data examining
some of these questions. The analysis
focused on male perpetrators of child
maltreatment and identifies clear
subgroups of male perpetrators. The
findings suggest that interventions of all
types may need to be more highly
differentiated for these different groups.
Follow-up of interest includes research
to gain a clearer picture of how the
various categories of perpetrators fit
within households to provide insights
into the service and recidivism
outcomes.
C. Field Initiated Research on Child
Abuse and Neglect
The generation of new knowledge for
understanding critical issues in child
abuse and neglect improves prevention,
identification, assessment and
treatment. Research areas to be
addressed may be those that will
expand the current knowledge base,
build on prior research, contribute to
practice enhancements, inform policy,
improve science and provide insights
into new approaches to the assessment,
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
prevention, intervention and treatment
of child maltreatment (i.e., physical
abuse, sexual abuse, emotional
maltreatment or neglect) on any of the
topics listed in (A) Legislative Topics,
(B) Other Topics, above, or any other
child maltreatment topic.
In addition to the topics cited above,
practitioners and researchers are
encouraged to propose other relevant
subjects for research topics in child
abuse and neglect.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. E6–1480 Filed 2–2–06; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P–0023]
Determination That TEQUIN
(Gatifloxacin) Injection, 10 Milligrams
per Milliliter (200 Milligrams), 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 TEQUIN (gatifloxacin) injection, 10
milligrams (mg) per milliliter (mL) (200
mg), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for gatifloxacin
injection, 10 mg/mL (200 mg).
FOR FURTHER INFORMATION CONTACT:
Elaine Tseng, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (the 1984
amendments) (Pub. L. 98–417), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors 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 typically a version of the drug
that was previously approved. Sponsors
of ANDAs do not have to repeat the
extensive clinical testing otherwise
E:\FR\FM\03FEN1.SGM
03FEN1
hsrobinson on PROD1PC70 with NOTICES
Federal Register / Vol. 71, No. 23 / Friday, February 3, 2006 / Notices
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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
TEQUIN (gatifloxacin) injection, 10
mg/mL (200 mg), is the subject of
approved NDA 21–062 held by BristolMyers Squibb. TEQUIN (gatifloxacin)
injection, 10 mg/mL (200 mg), is an
antibiotic used to treat adults with lung,
sinus, or urinary tract infections.
FDA approved the NDA for TEQUIN
(gatifloxacin) injection, 10 mg/mL (200
mg) and 10 mg/mL (400 mg), on
December 17, 1999. On January 27,
2003, FDA received revised product
labeling relating to several approved
supplements for TEQUIN (gatifloxacin).
This revised labeling deleted references
to TEQUIN (gatifloxacin) injection, 10
mg/mL (200 mg), indicating that this
product was no longer being marketed.
Therefore, it was moved from the
prescription drug product list to 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.
Apotex Corp., submitted a citizen
petition dated January 13, 2005 (Docket
No. 2005P–0023/CP1), under 21 CFR
10.30, requesting that the agency
determine whether TEQUIN
(gatifloxacin) injection, 10 mg/mL (200
mg), was withdrawn from sale for
reasons of safety or effectiveness. After
considering the citizen petition and
reviewing agency records, FDA has
determined that TEQUIN (gatifloxacin)
VerDate Aug<31>2005
15:55 Feb 02, 2006
Jkt 208001
injection, 10 mg/mL (200 mg), approved
under NDA 21–062, was not withdrawn
from sale for reasons of safety or
effectiveness. The petitioner identified
no data or other information suggesting
that TEQUIN (gatifloxacin) injection, 10
mg/mL (200 mg), was withdrawn from
sale as a result of safety or effectiveness
concerns. FDA’s independent
evaluation of relevant literature and
data has not uncovered anything that
would indicate that this product was
withdrawn for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list TEQUIN
(gatifloxacin) injection, 10 mg/mL (200
mg), in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book.
ANDAs that refer to TEQUIN
(gatifloxacin) injection, 10 mg/mL (200
mg), may be approved by the agency.
Dated: January 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1475 Filed 2–2–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0389]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SURPASS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SURPASS and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that animal drug product.
ADDRESSES: Submit written comments
and petitions 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Claudia V. Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
5859
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360b(j)) became effective and
runs until the approval phase begins.
The approval phase starts with the
initial submission of an application to
market the animal drug product and
continues until FDA grants permission
to market the drug product. Although
only a portion of a regulatory review
period may count toward the actual
amount of extension that the Director of
Patents and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
an animal drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing
the animal drug product SURPASS
(diclofenac sodium). SURPASS is
indicated for the control of pain and
inflammation associated with
osteoarthritis in tarsal, carpal,
metacarpophalangeal,
metatarsophalangeal, and proximal
interphalangeal (hock, knee, fetlock, and
pastern) joints in horses. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for SURPASS (U.S. Patent
No. 4,937,078) from Mezei Associates,
Ltd., and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
April 8, 2005, FDA advised the Patent
and Trademark Office that this animal
drug product had undergone a
regulatory review period and that the
approval of SURPASS represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 71, Number 23 (Friday, February 3, 2006)]
[Notices]
[Pages 5858-5859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1475]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P-0023]
Determination That TEQUIN (Gatifloxacin) Injection, 10 Milligrams
per Milliliter (200 Milligrams), 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
TEQUIN (gatifloxacin) injection, 10 milligrams (mg) per milliliter (mL)
(200 mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for gatifloxacin injection, 10 mg/mL (200
mg).
FOR FURTHER INFORMATION CONTACT: Elaine Tseng, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (the 1984
amendments) (Pub. L. 98-417), which authorized the approval of
duplicate versions of drug products approved under an ANDA procedure.
ANDA sponsors 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
typically a version of the drug that was previously approved. Sponsors
of ANDAs do not have to repeat the extensive clinical testing otherwise
[[Page 5859]]
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 generally known as the ``Orange
Book.'' Under FDA regulations, drugs are withdrawn 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).
Under 21 CFR 314.161(a)(1), the agency must determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness before an ANDA that refers to that listed drug may be
approved. FDA may not approve an ANDA that does not refer to a listed
drug.
TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), is the subject
of approved NDA 21-062 held by Bristol-Myers Squibb. TEQUIN
(gatifloxacin) injection, 10 mg/mL (200 mg), is an antibiotic used to
treat adults with lung, sinus, or urinary tract infections.
FDA approved the NDA for TEQUIN (gatifloxacin) injection, 10 mg/mL
(200 mg) and 10 mg/mL (400 mg), on December 17, 1999. On January 27,
2003, FDA received revised product labeling relating to several
approved supplements for TEQUIN (gatifloxacin). This revised labeling
deleted references to TEQUIN (gatifloxacin) injection, 10 mg/mL (200
mg), indicating that this product was no longer being marketed.
Therefore, it was moved from the prescription drug product list to 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.
Apotex Corp., submitted a citizen petition dated January 13, 2005
(Docket No. 2005P-0023/CP1), under 21 CFR 10.30, requesting that the
agency determine whether TEQUIN (gatifloxacin) injection, 10 mg/mL (200
mg), was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency records,
FDA has determined that TEQUIN (gatifloxacin) injection, 10 mg/mL (200
mg), approved under NDA 21-062, was not withdrawn from sale for reasons
of safety or effectiveness. The petitioner identified no data or other
information suggesting that TEQUIN (gatifloxacin) injection, 10 mg/mL
(200 mg), was withdrawn from sale as a result of safety or
effectiveness concerns. FDA's independent evaluation of relevant
literature and data has not uncovered anything that would indicate that
this product was withdrawn for reasons of safety or effectiveness.
Accordingly, the agency will continue to list TEQUIN (gatifloxacin)
injection, 10 mg/mL (200 mg), in the ``Discontinued Drug Product List''
section of the Orange Book. ANDAs that refer to TEQUIN (gatifloxacin)
injection, 10 mg/mL (200 mg), may be approved by the agency.
Dated: January 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1475 Filed 2-2-06; 8:45 am]
BILLING CODE 4160-01-S
