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That OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 53908-53909 [2011-22143]
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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withdrawn or withheld from sale for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withdrawn for reasons of safety or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mg; EQ 12.5 mg base, were withdrawn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withdrawn from sale for reasons of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]
BILLING CODE 4160–01–P
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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
Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
mg, were not discontinued from sale for
reasons of safety or effectiveness.
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 OPANA ER
(oxymorphone HCl) extended-release
tablets, 7.5 mg and 15 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioners have
identified no data or other information
suggesting that OPANA ER
(oxymorphone HCl) extended-release
tablets, 7.5 mg and 15 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of OPANA
ER (oxymorphone HCl) extended-release
tablets, 7.5 mg and 15 mg, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. In
addition, we have considered that the
7.5 mg and 15 mg strengths are
bracketed by other strengths that are
still being marketed. We have found no
information that would indicate that
OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15
mg, were withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list OPANA ER
(oxymorphone HCl) extended-release
tablets, 7.5 mg and 15 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 ANDAs that refer to these drug
products. Additional ANDAs that refer
to OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15
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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–22143 Filed 8–29–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
20:31 Aug 29, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0595]
Draft Guidance for Industry on Tablet
Scoring: Nomenclature, Labeling, and
Data for Evaluation; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Tablet Scoring:
Nomenclature, Labeling, and Data for
Evaluation.’’ This draft guidance
provides recommendations to sponsors
of new drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) regarding what criteria should
be met to facilitate the evaluation and
labeling of tablets that have been scored.
(A scoring feature facilitates tablet
splitting, which is the practice of
breaking or cutting a higher-strength
tablet into smaller portions.)
Specifically, this draft guidance
recommends guidelines to follow, data
to provide, and criteria to meet and
detail in an application to approve a
scored tablet; and nomenclature and
labeling for approved scored tablets.
This guidance does not address
specific finished-product release testing,
where additional requirements may be
appropriate for scored tablets.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 28,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
SUMMARY:
PO 00000
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Fmt 4703
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53909
FOR FURTHER INFORMATION CONTACT:
Russell Wesdyk, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4182,
Silver Spring, MD 20993–0002, 301–
796–2400.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Tablet Scoring: Nomenclature,
Labeling, and Data for Evaluation.’’ This
draft guidance provides
recommendations to sponsors of NDAs
and ANDAs regarding what criteria
should be met to facilitate the
evaluation and labeling of tablets that
have been scored. (A scoring feature
facilitates tablet splitting, which is the
practice of breaking or cutting a higherstrength tablet into smaller portions.)
Specifically, this draft guidance
recommends:
• Guidelines to follow, data to
provide, and criteria to meet and detail
in an application to approve a scored
tablet.
• Nomenclature and labeling for
approved scored tablets.
The Agency has previously
considered tablet scoring as an issue
when determining whether a generic
drug product is the same as the
reference listed drug (RLD). One
characteristic of a tablet dosage form is
that it may be manufactured with a
score or scores. This characteristic is
useful because the score can be used to
facilitate the splitting of the tablet into
fractions when less than a full tablet is
desired for a dose. Although there are
no standards or regulatory requirements
that specifically address scoring of
tablets, the Agency recognizes the need
for consistent scoring between a generic
product and its RLD.
Consistent scoring ensures that the
patient is able to adjust the dose, by
splitting the tablet, in the same manner
as the RLD. This enables the patient to
switch between products made by
different manufacturers without
encountering problems related to the
dose. In addition, consistent scoring
ensures that neither the generic product
nor the RLD has an advantage in the
marketplace because one is scored and
one is not.
CDER’s Drug Safety Oversight Board
considered the practice of tablet
splitting at its October 2009 and
November 2010 meetings. During those
meetings, they discussed how insurance
companies and doctors are increasingly
recommending that patients split
tablets, either to adjust the patients’
dose or as a cost-saving measure.
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53908-53909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22143]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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.
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).
Under Sec. 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 Sec. Sec. 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 Sec. 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 Sec. 10.30, requesting that the Agency determine that
OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15
[[Page 53909]]
mg, were not discontinued from sale for reasons of safety or
effectiveness.
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 OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioners have identified no
data or other information suggesting that OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15 mg, were withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of OPANA ER (oxymorphone HCl)
extended-release tablets, 7.5 mg and 15 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. In addition, we have considered that the
7.5 mg and 15 mg strengths are bracketed by other strengths that are
still being marketed. We have found no information that would indicate
that OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15
mg, were withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list OPANA ER (oxymorphone
HCl) extended-release tablets, 7.5 mg and 15 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
ANDAs that refer to these drug products. Additional ANDAs that refer to
OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22143 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P
