Determination That AVALIDE (Hydrochlorothiazide and Irbesartan), Oral Tablets, 25 Milligrams/300 Milligrams and 12.5 Milligrams/75 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 1695-1696 [2012-312]
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1695
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Annual
number of
respondents
Instrument
Semi-structured interviews Head Start Health Managers ...............................
Semi-structured interviews Head Start Teachers and Family Service Workers ................................................................................................................
Estimated Total Annual Burden
Hours: 4394.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@acf.
hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: January 4, 2012.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012–262 Filed 1–10–12; 8:45 am]
pmangrum on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4184–22–M
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15:02 Jan 10, 2012
Jkt 226001
.75
30
60
1
.75
45
[Docket Nos. FDA–2011–P–0743 and FDA–
2011–P–0822]
Determination That AVALIDE
(Hydrochlorothiazide and Irbesartan),
Oral Tablets, 25 Milligrams/300
Milligrams and 12.5 Milligrams/75
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
that AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 milligrams
(mg)/300 mg and 12.5 mg/75 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
hydrochlorothiazide and irbesartan, oral
tablets, 25 mg/300 mg and 12.5 mg/75
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Jane
Inglese, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6210, Silver Spring,
MD 20993–0002, (301) 796–3601.
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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Total
annual
burden
hours
1
Food and Drug Administration
ACTION:
Average
burden
hours per
response
40
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
(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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg, are the subject of
NDA 20–758, held by Sanofi-Aventis,
and initially approved on September 30,
1997. AVALIDE is indicated for
treatment of hypertension in patients
whose blood pressure is not adequately
controlled on monotherapy. AVALIDE
is also indicated for initial therapy for
hypertension in patients who are likely
to need multiple drugs to achieve their
blood pressure goals.
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg are currently listed
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
EAS Consulting Group, LLC on behalf
of Aurobindo Pharmaceuticals, Ltd.
submitted a citizen petition dated
October 11, 2011 (Docket No. FDA–
2011–P–0743), under § 10.30 (21 CFR
10.30), requesting that the Agency
E:\FR\FM\11JAN1.SGM
11JAN1
pmangrum on DSK3VPTVN1PROD with NOTICES
1696
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices
determine whether AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg, were
withdrawn from sale for reasons of
safety or effectiveness. In addition,
Lupin Pharmaceuticals, Inc. submitted a
citizen petition dated November 10,
2011 (Docket No. FDA–2011–P–0822),
under § 10.30, also requesting that the
Agency determine whether AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg, were
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petitions did not address the
12.5 mg/75 mg strength, that strength
has also been discontinued. On our own
initiative, we have also determined
whether that strength was withdrawn
for safety or effectiveness reasons.
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 AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg were not withdrawn for reasons
of safety or effectiveness. The
petitioners have identified no data or
other information suggesting that
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg, 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 AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg, 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
VerDate Mar<15>2010
15:02 Jan 10, 2012
Jkt 226001
Agency will advise ANDA applicants to
submit such labeling.
Dated: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–312 Filed 1–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 14, 2012, from 7:30 a.m.
to 3 p.m.
Location: Gaylord National Hotel and
Convention Center, Maryland Ballroom
C, 201 Waterfront St., National Harbor,
MD 20745. The hotel’s phone number is
(301) 965–4000.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, FAX: (301) 847–8533, email:
ACPS–CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–(800) 741–8138 ((301) 443–0572 in
the Washington, DC area), and follow
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
the clinical pharmacology aspects of
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
pediatric clinical trial design and dosing
to optimize pediatric drug development.
FDA will seek input on how to
strategically inform pediatric clinical
trial design and dosing by utilizing
existing knowledge, including available
adult and nonclinical data. The
discussion will include the role of
modeling and simulation including
physiologically-based pharmacokinetic
modeling in pediatric drug
development. Modeling and simulation
is the application of mathematical
approaches to predicting what will
happen in a clinical trial with pediatric
patients when a particular dose of a
drug is used.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 29, 2012.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:45 a.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 21, 2012. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 22, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1695-1696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-P-0743 and FDA-2011-P-0822]
Determination That AVALIDE (Hydrochlorothiazide and Irbesartan),
Oral Tablets, 25 Milligrams/300 Milligrams and 12.5 Milligrams/75
Milligrams, 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) has determined that
AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25
milligrams (mg)/300 mg and 12.5 mg/75 mg, were not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
hydrochlorothiazide and irbesartan, oral tablets, 25 mg/300 mg and 12.5
mg/75 mg, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Jane Inglese, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6210, Silver Spring, MD 20993-0002, (301)
796-3601.
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.
AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 mg/
300 mg and 12.5 mg/75 mg, are the subject of NDA 20-758, held by
Sanofi-Aventis, and initially approved on September 30, 1997. AVALIDE
is indicated for treatment of hypertension in patients whose blood
pressure is not adequately controlled on monotherapy. AVALIDE is also
indicated for initial therapy for hypertension in patients who are
likely to need multiple drugs to achieve their blood pressure goals.
AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 mg/
300 mg and 12.5 mg/75 mg are currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
EAS Consulting Group, LLC on behalf of Aurobindo Pharmaceuticals,
Ltd. submitted a citizen petition dated October 11, 2011 (Docket No.
FDA-2011-P-0743), under Sec. 10.30 (21 CFR 10.30), requesting that the
Agency
[[Page 1696]]
determine whether AVALIDE (hydrochlorothiazide and irbesartan), oral
tablets, 25 mg/300 mg, were withdrawn from sale for reasons of safety
or effectiveness. In addition, Lupin Pharmaceuticals, Inc. submitted a
citizen petition dated November 10, 2011 (Docket No. FDA-2011-P-0822),
under Sec. 10.30, also requesting that the Agency determine whether
AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 mg/300
mg, were withdrawn from sale for reasons of safety or effectiveness.
Although the citizen petitions did not address the 12.5 mg/75 mg
strength, that strength has also been discontinued. On our own
initiative, we have also determined whether that strength was withdrawn
for safety or effectiveness reasons.
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 AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg and 12.5 mg/75 mg were not
withdrawn for reasons of safety or effectiveness. The petitioners have
identified no data or other information suggesting that AVALIDE
(hydrochlorothiazide and irbesartan), oral tablets, 25 mg/300 mg and
12.5 mg/75 mg were withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 mg/
300 mg and 12.5 mg/75 mg from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 mg/
300 mg and 12.5 mg/75 mg were not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list AVALIDE
(hydrochlorothiazide and irbesartan), oral tablets, 25 mg/300 mg and
12.5 mg/75 mg, 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
AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 mg/300
mg and 12.5 mg/75 mg, 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: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-312 Filed 1-10-12; 8:45 am]
BILLING CODE 4160-01-P
