Determination That TRANDATE (Labetalol Hydrochloride) Tablets, 300 Milligrams and 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 81617-81618 [2010-32507]
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
81617
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Section 523 of the FD&C Act
No. of
respondents
Annual
frequency per
response
Total annual
responses
Hours per
response
Requests for accreditation ...................................................
510(k) reviews conducted by accredited third parties .........
Total ..............................................................................
1
10
........................
1
26
........................
1
260
........................
24
40
........................
1 There
Total hours
24
10,400
10,424
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Section 523 of the FD&C Act
No. of
recordkeepers
Annual
frequency per
recordkeeping
Total annual
records
Hours
per record
Total hours
510(k) reviews ......................................................................
10
26
260
10
2,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32603 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0326]
Determination That TRANDATE
(Labetalol Hydrochloride) Tablets, 300
Milligrams and 400 Milligrams, Were
Not Withdrawn From Sale for Reasons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 TRANDATE (labetalol
hydrochloride) tablets, 300 milligrams
(mg) and 400 mg, were not withdrawn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
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as the
ANDAs meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Deborah Livornese, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306,
Silver Spring, MD 20993–0002, 301–
796–0719.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
22:37 Dec 27, 2010
Jkt 223001
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
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 (§ 314.162 (21
CFR 314.162)). Under § 314.161(a)(1) (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. Under § 314.161(a)(2), FDA must
determine whether a listed drug was
withdrawn from sale for reasons of
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
safety or effectiveness whenever a listed
drug is voluntarily withdrawn from sale
and ANDAs that refer to the listed drug
have been approved. Section 314.161(d)
provides that if FDA determines that a
listed drug was withdrawn from sale for
reasons of safety or effectiveness, the
Agency will initiate proceedings that
could result in the withdrawal of
approval of the ANDAs that refer to the
listed drug.
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, are the
subject of NDA 18–716, held by
Prometheus Laboratories, Inc., and
initially approved on August 1, 1984.
TRANDATE is indicated for the
management of hypertension.
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. TRANDATE (labetalol
hydrochloride) tablets, 400 mg, have
never been marketed. In previous
instances (see, e.g., 72 FR 9763, March
5, 2007; 61 FR 25497, May 21, 1996), the
Agency has determined that, for
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
JRRapoza Associates, Inc., submitted a
citizen petition dated June 16, 2010
(Docket No. FDA–2010–P–0326), under
21 CFR 10.30, requesting that the
Agency determine whether TRANDATE
(labetalol hydrochloride) tablets, 300
mg, were withdrawn from sale for
reasons of safety or effectiveness.
Although the citizen petition did not
address the 400 mg strength, on our own
initiative, we have also determined
whether that strength was withdrawn
for safety or effectiveness reasons.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
E:\FR\FM\28DEN1.SGM
28DEN1
81618
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events and 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 TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400
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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to the
TRANDATE products listed in this
document. Additional ANDAs that refer
to these products 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: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32507 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
emcdonald on DSK2BSOYB1PROD with NOTICES
Anesthetic and Life Support Drugs
Advisory Committee; 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.
VerDate Mar<15>2010
22:37 Dec 27, 2010
Jkt 223001
Name of Committee: Anesthetic and Life
Support Drugs Advisory Committee.
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 10, 2011, from 8 a.m. to 4:30 p.m.
Location: FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability, visitor
parking and transportation may be accessed
at: https://www.fda.gov/AdvisoryCommittees/
default.htm; under the heading ‘‘Resources
for You’’, click on ‘‘White Oak Conference
Center Parking and Transportation
Information for FDA Advisory Committee
Meetings’’. Please note that visitors to the
White Oak Campus must enter through
Building 1.
Contact Person: Kalyani Bhatt, 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, e-mail: kalyani.bhatt@fda.hhs.gov, or
FDA Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for upto-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: On March 10, 2011, the committee
will: (1) Receive updates regarding
neurodegenerative findings (findings related
to degeneration in the nervous system) in
juvenile animals exposed to anesthetic drugs,
as well as results from human
epidemiological studies using anesthesia in
children (information related to studies of
patterns and causes of disease); (2) discuss
the relevance of these findings to pediatric
patients and provide guidance for future
preclinical and clinical studies; and (3)
discuss the potential implications of these
data upon the practice of pediatric anesthesia
as well as the communication of the risk of
sedative/anesthetic agents to prescribers and
parents.
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
committee. Written submissions may be
made to the contact person on or before
February 24, 2011. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.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 15, 2011. 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 16, 2011.
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 accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Kalyani
Bhatt at least 7 days in advance of the
meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm
for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–32591 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Request for Notification From
Consumer Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
on Public Advisory Committees or
Panels and Request for Nominations
for Voting and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\28DEN1.SGM
Notice.
28DEN1
]]>Agencies
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81617-81618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-P-0326]
Determination That TRANDATE (Labetalol Hydrochloride) Tablets,
300 Milligrams and 400 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
TRANDATE (labetalol hydrochloride) tablets, 300 milligrams (mg) and 400
mg, were 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 these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as the
ANDAs meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Deborah Livornese, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-0719.
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 approved 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
(Sec. 314.162 (21 CFR 314.162)). Under Sec. 314.161(a)(1) (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. Under Sec.
314.161(a)(2), FDA must determine whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness whenever a listed drug
is voluntarily withdrawn from sale and ANDAs that refer to the listed
drug have been approved. Section 314.161(d) provides that if FDA
determines that a listed drug was withdrawn from sale for reasons of
safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
TRANDATE (labetalol hydrochloride) tablets, 300 mg and 400 mg, are
the subject of NDA 18-716, held by Prometheus Laboratories, Inc., and
initially approved on August 1, 1984. TRANDATE is indicated for the
management of hypertension. TRANDATE (labetalol hydrochloride) tablets,
300 mg and 400 mg, are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book. TRANDATE (labetalol
hydrochloride) tablets, 400 mg, have never been marketed. In previous
instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21,
1996), the Agency has determined that, for purposes of Sec. Sec.
314.161 and 314.162, never marketing an approved drug product is
equivalent to withdrawing the drug from sale.
JRRapoza Associates, Inc., submitted a citizen petition dated June
16, 2010 (Docket No. FDA-2010-P-0326), under 21 CFR 10.30, requesting
that the Agency determine whether TRANDATE (labetalol hydrochloride)
tablets, 300 mg, were withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 400 mg
strength, on our own initiative, we have also determined whether that
strength was withdrawn for safety or effectiveness reasons.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that
[[Page 81618]]
TRANDATE (labetalol hydrochloride) tablets, 300 mg and 400 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that TRANDATE
(labetalol hydrochloride) tablets, 300 mg and 400 mg, were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events and 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 TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to the TRANDATE products listed in this
document. Additional ANDAs that refer to these products 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: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32507 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P
