Determination That PREZISTA (darunavir) Tablets, 300 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 2555 [2012-847]
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Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices
estimates for this request. The
availability of the form, and the
opportunity to provide the information
in electronic format, could reduce this
estimate. However, as a conservative
approach for the purpose of this
analysis, FDA is assuming that the
availability of the form and the
opportunity to submit the information
in electronic format will have no effect
on the average time to prepare a GRAS
notification.
Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–783 Filed 1–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0756]
Determination That PREZISTA
(darunavir) Tablets, 300 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Was Not Withdrawn From Sale for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 PREZISTA (darunavir) Tablets, 300
milligrams (mg), was not withdrawn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
darunavir tablets, 300 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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:07 Jan 17, 2012
Jkt 226001
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.
PREZISTA (darunavir) Tablets, 300
mg, is the subject of NDA 21–976, held
by Tibotec, Inc., and initially approved
on June 23, 2006. PREZISTA is a human
immunodeficiency virus (HIV–1)
protease inhibitor indicated for the
treatment of HIV–1 infection in adult
patients. PREZISTA is also indicated for
the treatment of HIV–1 infection in
pediatric patients 6 years of age and
older. PREZISTA must be
coadministered with ritonavir
(PREZISTA/ritonavir) and with other
antiretroviral agents.
PREZISTA (darunavir) Tablets, 300
mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lupin Pharmaceuticals, Inc. (Lupin),
submitted a citizen petition dated
October 14, 2011 (Docket No. FDA–
2011–P–0756), under 21 CFR 10.30,
requesting that the Agency determine
whether PREZISTA (darunavir) Tablets,
300 mg, was 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 PREZISTA (darunavir) Tablets, 300
mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner
Lupin has identified no data or other
information suggesting that PREZISTA
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
2555
(darunavir) Tablets, 300 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
PREZISTA (darunavir) Tablets, 300 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 PREZISTA (darunavir)
Tablets, 300 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 PREZISTA
(darunavir) Tablets, 300 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 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–847 Filed 1–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0020 (formerly
Docket No. 2007D–0249)]
Guidance for Industry: Preparation of
Investigational Device Exemptions and
Investigational New Drug Applications
for Products Intended To Repair or
Replace Knee Cartilage; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Preparation of
IDEs and INDs for Products Intended to
Repair or Replace Knee Cartilage’’ dated
December 2011. The guidance
document provides sponsors of an
investigational device exemption
application (IDE) or an investigational
new drug application (IND)
recommendations about certain
information that should be included in
SUMMARY:
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Notices]
[Page 2555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0756]
Determination That PREZISTA (darunavir) Tablets, 300 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
PREZISTA (darunavir) Tablets, 300 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
darunavir tablets, 300 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.
PREZISTA (darunavir) Tablets, 300 mg, is the subject of NDA 21-976,
held by Tibotec, Inc., and initially approved on June 23, 2006.
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor
indicated for the treatment of HIV-1 infection in adult patients.
PREZISTA is also indicated for the treatment of HIV-1 infection in
pediatric patients 6 years of age and older. PREZISTA must be
coadministered with ritonavir (PREZISTA/ritonavir) and with other
antiretroviral agents.
PREZISTA (darunavir) Tablets, 300 mg, is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Lupin Pharmaceuticals, Inc. (Lupin), submitted a citizen petition
dated October 14, 2011 (Docket No. FDA-2011-P-0756), under 21 CFR
10.30, requesting that the Agency determine whether PREZISTA
(darunavir) Tablets, 300 mg, was 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 Sec. 314.161 that PREZISTA (darunavir)
Tablets, 300 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner Lupin has identified no data or other
information suggesting that PREZISTA (darunavir) Tablets, 300 mg, was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of PREZISTA
(darunavir) Tablets, 300 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 PREZISTA (darunavir)
Tablets, 300 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 PREZISTA (darunavir) Tablets, 300 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 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-847 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P
