Determination That WILPO (phentermine hydrochloride) Tablets, 8 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 7583-7584 [2012-3232]
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erowe on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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time after the drug has been withdrawn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.
JENLOGA (clonidine hydrochloride)
Extended-Release Tablets, 0.1 mg and
0.2 mg, are the subject of NDA 22–331,
held by Shionogi Pharma, Inc., initially
approved on September 29, 2009.
JENLOGA is indicated for the treatment
of hypertension. Shionogi Pharma has
never marketed JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 mg and 0.2 mg. 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.
Actavis, Inc. submitted a citizen
petition dated April 20, 2011 (Docket
No. FDA–2011–P–0291), under 21 CFR
10.30, requesting that the Agency
determine whether JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 mg and 0.2 mg, were
withdrawn from sale for reasons of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 JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 mg and 0.2 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that JENLOGA
(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg,
were withdrawn from sale for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of JENLOGA
(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg,
from sale. We have found no
information that would indicate that
these products were withdrawn from
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
sale for reasons of safety or
effectiveness.
Accordingly, FDA will continue to list
JENLOGA (clonidine hydrochloride)
Extended-Release Tablets, 0.1 mg and
0.2 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 JENLOGA
(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 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: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3222 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0701]
Determination That WILPO
(phentermine hydrochloride) Tablets, 8
Milligrams, Was 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 WILPO (phentermine
hydrochloride) Tablets, 8 Milligrams
(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 phentermine
hydrochloride tablets, 8 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, 301–796–3472.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
SUMMARY:
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
7583
(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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
WILPO (phentermine hydrochloride)
Tablets, 8 mg is the subject of NDA
012737, held by Sandoz, Inc. WILPO is
indicated in the management of
exogenous obesity as a short term
adjunct (a few weeks) in a regimen of
weight reduction based on caloric
restriction.
WILPO (phentermine hydrochloride)
Tablets, 8 mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
KVK–Tech, Inc. (KVK–Tech),
submitted a citizen petition dated
September 22, 2011 (Docket No. FDA–
2011–P–0701), under 21 CFR 10.30,
requesting that the Agency determine
whether WILPO (phentermine
hydrochloride) Tablets, 8 mg, was
withdrawn from sale for reasons of
safety or effectiveness. After considering
the citizen petition and reviewing
E:\FR\FM\13FEN1.SGM
13FEN1
7584
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
Agency records and based on the
information we have at this time, FDA
has determined under § 314.161 that
WILPO (phentermine hydrochloride)
Tablets, 8 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner KVK–Tech has identified no
data or other information suggesting that
WILPO (phentermine hydrochloride)
Tablets, 8 mg, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
WILPO (phentermine hydrochloride)
Tablets, 8 mg, 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 WILPO (phentermine
hydrochloride) Tablets, 8 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 WILPO (phentermine hydrochloride)
Tablets, 8 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: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3232 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0083]
erowe on DSK2VPTVN1PROD with NOTICES
Draft Guidance for Industry on Heparin
for Drug and Medical Device Use;
Monitoring Crude Heparin for Quality;
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 ‘‘Heparin for Drug and
SUMMARY:
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
Medical Device Use: Monitoring Crude
Heparin for Quality.’’ This draft
guidance is intended to alert
manufacturers of active pharmaceutical
ingredients (APIs), pharmaceutical and
medical device manufacturers of
finished products, and others to the
potential risk of crude heparin
contamination.
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
electronic or written comments on the
draft guidance by April 13, 2012.
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.
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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Frank W. Perrella, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4337,
Silver Spring, MD 20993–0002, 301–
796–3265; or Dennis M. Bensley, Jr.,
Center for Veterinary Medicine (HFV–
140), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855,
240–276–8268; or Jason Brookbank,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 3558, Silver Spring, MD 20993–
0002, 301–796–5770.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Heparin for Drug and Medical Device
Use: Monitoring Crude Heparin for
Quality.’’ This draft guidance provides
recommendations that will help API
manufacturers, pharmaceutical and
medical device manufacturers of
finished products, and others, to better
control their use of crude heparin that
might contain oversulfated chondroitin
sulfate (OSCS) or non-porcine material
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
(especially ruminant material)
contaminants. This draft guidance on
crude heparin recommends strategies to
test for contamination and should be
used in addition to the United States
Pharmacopeia (USP) monograph testing
required for other forms of heparin to
detect the presence of OSCS.
Following reports of serious adverse
events (including deaths) among
patients injected with heparin sodium
in 2008, FDA identified the contaminant
OSCS in heparin API manufactured in
China. FDA is also concerned about the
potential for contamination of heparin
with the bovine spongiform
encephalopathy (BSE) agent derived
from ruminant materials. The control of
the quality of crude heparin is critical
to ensure the safety of drugs and devices
and to protect public health. FDA
developed this draft guidance to alert
manufacturers to the risks of crude
heparin contaminants and to
recommend strategies to ensure that the
heparin supply chain is not
contaminated with OSCS or any nonporcine origin material, especially
ruminant material (unless specifically
approved or cleared as part of drug or
medical device application).
The draft guidance recommends that
manufacturers test and confirm the
species origin of crude heparin in each
shipment before use in the manufacture
or preparation of a drug or medical
device containing heparin. The test
method should be qualified for use in
testing crude heparin and for the
identification of species origin. The
method should be based on good
scientific principles (e.g., sufficient
accuracy and specificity) and possess a
level of sensitivity commensurate with
the current state of scientific knowledge
and risk. Likewise, the draft guidance
recommends that manufacturers test for
OSCS in crude heparin in each
shipment before use, using a qualified
test method that is suitable for detecting
low levels of OSCS concentrations and
is based on good scientific principles.
Manufacturers should reject for use and
control or destroy crude heparin found
to contain any amount of OSCS and
notify FDA of any such finding. The
draft guidance also recommends that
manufacturers identify and audit crude
heparin suppliers and heparin API
suppliers to ensure conformance to
current good manufacturing practice
(CGMP), employ the controls described
in the guidance for industry ‘‘Q7 Good
Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients,’’ and
comply with the quality system
regulations (as applicable).
This draft guidance is being issued
consistent with FDA’s good guidance
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7583-7584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3232]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0701]
Determination That WILPO (phentermine hydrochloride) Tablets, 8
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
WILPO (phentermine hydrochloride) Tablets, 8 Milligrams (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 phentermine hydrochloride tablets, 8 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, 301-796-3472.
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.
WILPO (phentermine hydrochloride) Tablets, 8 mg is the subject of
NDA 012737, held by Sandoz, Inc. WILPO is indicated in the management
of exogenous obesity as a short term adjunct (a few weeks) in a regimen
of weight reduction based on caloric restriction.
WILPO (phentermine hydrochloride) Tablets, 8 mg, is currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
KVK-Tech, Inc. (KVK-Tech), submitted a citizen petition dated
September 22, 2011 (Docket No. FDA-2011-P-0701), under 21 CFR 10.30,
requesting that the Agency determine whether WILPO (phentermine
hydrochloride) Tablets, 8 mg, was withdrawn from sale for reasons of
safety or effectiveness. After considering the citizen petition and
reviewing
[[Page 7584]]
Agency records and based on the information we have at this time, FDA
has determined under Sec. 314.161 that WILPO (phentermine
hydrochloride) Tablets, 8 mg, was not withdrawn for reasons of safety
or effectiveness. The petitioner KVK-Tech has identified no data or
other information suggesting that WILPO (phentermine hydrochloride)
Tablets, 8 mg, was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of WILPO (phentermine hydrochloride) Tablets, 8 mg, 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 WILPO (phentermine
hydrochloride) Tablets, 8 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 WILPO (phentermine hydrochloride)
Tablets, 8 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: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3232 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P
