Determination That TALWIN COMPOUND (Aspirin; Pentazocine Hydrochloride) Tablets, 325 Milligrams; Equivalent to 12.5 Milligram Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 53907-53908 [2011-22145]
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53907
Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
include all applicable State procedures,
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Families (ACF) or a different format, on
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at 45 CFR part 400.
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of this State Plan, as all States are
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plan and are in compliance with
regulations at 45 CFR 400.4 400.9. Per
45 CFR 400.4(b), States need only certify
that the approved plan is current and
continues in effect, no later than 30 days
after the beginning of the Federal fiscal
year. Consistent with regulations, if
States wish to revise or amend the plan,
a revised plan or plan amendment must
be submitted to ORR as described at 45
CFR 400.7 400.9.
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ANNUAL BURDEN ESTIMATES
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respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
Title IV State Plan ............................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
50
1
15
750
Estimated Total Annual Burden
Hours: 750.
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–22078 Filed 8–29–11; 8:45 am]
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20:31 Aug 29, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0460]
Determination That TALWIN
COMPOUND (Aspirin; Pentazocine
Hydrochloride) Tablets, 325 Milligrams;
Equivalent to 12.5 Milligram Base,
Were Not Withdrawn From Sale for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 TALWIN COMPOUND (aspirin;
pentazocine hydrochloride (HCl))
tablets, 325 milligrams (mg); equivalent
to (EQ) 12.5 mg base, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for aspirin;
pentazocine HCl tablets, 325 mg; EQ
12.5 mg base, 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, 301–796–3601.
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
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, are the subject of NDA
016891, held by Sanofi-aventis U.S., and
initially approved on November 12,
1975. TALWIN COMPOUND tablets are
indicated for the relief of moderate pain.
TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, are currently listed in the
E:\FR\FM\30AUN1.SGM
30AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
53908
Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated June
7, 2011 (Docket No. FDA–2011–P–
0460), under 21 CFR 10.30, requesting
that the Agency determine whether
TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, have been voluntarily
withdrawn or withheld 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 TALWIN COMPOUND
(aspirin; pentazocine HCl) tablets, 325
mg; EQ 12.5 mg base, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that TALWIN COMPOUND
(aspirin; pentazocine HCl) tablets, 325
mg; EQ 12.5 mg base, were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, 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 TALWIN COMPOUND
(aspirin; pentazocine HCl) tablets, 325
mg; EQ 12.5 mg base, 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 TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, 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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–22145 Filed 8–29–11; 8:45 am]
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20:31 Aug 29, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–P–0182 and FDA–
2011–P–0209]
Determination That OPANA ER
(Oxymorphone Hydrochloride)
Extended-Release Tablets, 7.5
Milligrams and 15 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 OPANA ER (oxymorphone
hydrochloride (HCl)) extended-release
tablets, 7.5 milligrams (mg) and 15 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 for
oxymorphone HCl extended-release
tablets, 7.5 mg and 15 mg, if all other
legal and regulatory requirements are
met.
SUMMARY:
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, 301–796–3601.
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.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved; (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved; and (3) when a person
petitions for such a determination under
§§ 10.25(a) and 10.30 (21 CFR 10.25(a)
and 10.30). 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.
OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15
mg, are the subject of NDA 021610, held
by Endo Pharmaceuticals, and initially
approved on June 22, 2006. OPANA ER
is indicated for the relief of moderate to
severe pain in patients requiring
continuous, around-the-clock opioid
treatment for an extended period of
time.
OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15
mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. There are
approved ANDAs for oxymorphone HCl
extended-release tablets, 7.5 mg and 15
mg; these ANDAs are listed in the
Orange Book. The other strengths of
OPANA ER—both lower and higher
strengths than 7.5 mg and 15 mg—
continue to be marketed.
Watson Laboratories, Inc., submitted a
citizen petition dated March 21, 2011
(Docket No. FDA–2011–P–0182), under
§ 10.30, requesting that the Agency
determine whether OPANA ER
(oxymorphone HCl) extended-release
tablets, 7.5 mg and 15 mg, were
voluntarily withdrawn from sale for
reasons of safety or effectiveness. In
addition, K&L Gates submitted a citizen
petition dated March 25, 2011 (Docket
No. FDA–2011–P–0209), under § 10.30,
requesting that the Agency determine
that OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53907-53908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22145]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0460]
Determination That TALWIN COMPOUND (Aspirin; Pentazocine
Hydrochloride) Tablets, 325 Milligrams; Equivalent to 12.5 Milligram
Base, 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
TALWIN COMPOUND (aspirin; pentazocine hydrochloride (HCl)) tablets, 325
milligrams (mg); equivalent to (EQ) 12.5 mg base, were not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
aspirin; pentazocine HCl tablets, 325 mg; EQ 12.5 mg base, 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, 301-796-3601.
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.
TALWIN COMPOUND (aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5
mg base, are the subject of NDA 016891, held by Sanofi-aventis U.S.,
and initially approved on November 12, 1975. TALWIN COMPOUND tablets
are indicated for the relief of moderate pain.
TALWIN COMPOUND (aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5
mg base, are currently listed in the
[[Page 53908]]
``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated June 7, 2011 (Docket No. FDA-2011-P-0460), under 21 CFR 10.30,
requesting that the Agency determine whether TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ 12.5 mg base, have been
voluntarily withdrawn or withheld 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 TALWIN COMPOUND (aspirin; pentazocine HCl)
tablets, 325 mg; EQ 12.5 mg base, were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that TALWIN COMPOUND (aspirin; pentazocine HCl)
tablets, 325 mg; EQ 12.5 mg base, were withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of TALWIN COMPOUND (aspirin; pentazocine HCl)
tablets, 325 mg; EQ 12.5 mg base, 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 TALWIN COMPOUND
(aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5 mg base, 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 TALWIN COMPOUND
(aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5 mg base, 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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22145 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P
