Determination That MEPRON (Atovaquone) Tablets, 250 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27575 [E7-9348]
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Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices
OMB control number 0910–0599. The
approval expires on May 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9436 Filed 5–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0372]
Determination That MEPRON
(Atovaquone) Tablets, 250 milligrams,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that MEPRON (atovaquone) tablets, 250
milligrams (mg), were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
atovaquone tablets, 250 mg.
FOR FURTHER INFORMATION CONTACT:
Christine F. Rogers, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors 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. Sponsors of
ANDAs 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
VerDate Aug<31>2005
15:27 May 15, 2007
Jkt 211001
Food, Drug, and Cosmetic Act (the 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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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 (§ 314.161(a)(1)
(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.
MEPRON (atovaquone) tablets, 250
mg, are the subject of approved NDA
20–259 held by GlaxoSmithKline
(Glaxo). MEPRON (atovaquone) tablets,
250 mg, approved November 25, 1992,
are indicated for the prevention of
Pneumocystis carinii pneumonia in
patients who are intolerant to
trimethoprim-sulfamethoxazole (TMPSMX). Glaxo ceased marketing
MEPRON (atovaquone) tablets, 250 mg,
in 1995.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated
September 7, 2006 (Docket No. 2006P–
0372/CP1), under 21 CFR 10.30,
requesting that the agency determine, as
described in § 314.161, whether
MEPRON (atovaquone) tablets, 250 mg,
were withdrawn from sale for reasons of
safety or effectiveness.The agency has
determined that Glaxo’s MEPRON
(atovaquone) tablets, 250 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that MEPRON
tablets, 250 mg, were withdrawn from
sale as a result of safety or effectiveness
concerns. FDA has independently
evaluated relevant literature and data
for adverse event reports and has found
no information that would indicate this
product was withdrawn for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing its records, FDA
determines that, for the reasons outlined
in this notice, Glaxo’s MEPRON
(atovaquone) tablets, 250 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will list MEPRON (atovaquone)
tablets, 250 mg, in the ‘‘Discontinued
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
27575
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 oreffectiveness.
ANDAs that refer to MEPRON
(atovaquone) tablets, 250 mg, may be
approved by the agency as long as they
meet all relevant legal and regulatory
requirements for the approval of
ANDAs.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9348 Filed 5–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0112]
Guidance for Industry on Clinical Trial
Endpoints for the Approval of Cancer
Drugs and Biologics; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Clinical Trial Endpoints for
the Approval of Cancer Drugs and
Biologics.’’ This guidance provides
recommendations to applicants on
endpoints for cancer clinical trials
submitted to FDA to support
effectiveness claims in new drug
applications, biologics license
applications, or supplemental
applications. Applicants are encouraged
to use this guidance to design cancer
clinical trials and to discuss protocols
with the agency. This guidance provides
background information and discusses
general regulatory principles.
Additional companion guidances will
follow and will focus on endpoints for
specific cancer types (e.g., lung cancer,
colon cancer) to support drug approval
or labeling claims. This guidance, and
the subsequent indication-specific
guidances, should speed the
development and improve the quality of
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support anticancer effectiveness claims.
DATES: Submit written or electronic
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ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Page 27575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9348]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0372]
Determination That MEPRON (Atovaquone) Tablets, 250 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
MEPRON (atovaquone) tablets, 250 milligrams (mg), were not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
atovaquone tablets, 250 mg.
FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors 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. Sponsors of ANDAs 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 (the 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 generally known as the
``Orange Book.'' Under FDA regulations, drugs are withdrawn 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. 314.161(a)(1) (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.
MEPRON (atovaquone) tablets, 250 mg, are the subject of approved
NDA 20-259 held by GlaxoSmithKline (Glaxo). MEPRON (atovaquone)
tablets, 250 mg, approved November 25, 1992, are indicated for the
prevention of Pneumocystis carinii pneumonia in patients who are
intolerant to trimethoprim-sulfamethoxazole (TMP-SMX). Glaxo ceased
marketing MEPRON (atovaquone) tablets, 250 mg, in 1995.
Lachman Consultant Services, Inc., submitted a citizen petition
dated September 7, 2006 (Docket No. 2006P-0372/CP1), under 21 CFR
10.30, requesting that the agency determine, as described in Sec.
314.161, whether MEPRON (atovaquone) tablets, 250 mg, were withdrawn
from sale for reasons of safety or effectiveness.The agency has
determined that Glaxo's MEPRON (atovaquone) tablets, 250 mg, were not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
MEPRON tablets, 250 mg, were withdrawn from sale as a result of safety
or effectiveness concerns. FDA has independently evaluated relevant
literature and data for adverse event reports and has found no
information that would indicate this product was withdrawn for reasons
of safety or effectiveness.
After considering the citizen petition and reviewing its records,
FDA determines that, for the reasons outlined in this notice, Glaxo's
MEPRON (atovaquone) tablets, 250 mg, were not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will list
MEPRON (atovaquone) tablets, 250 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
oreffectiveness. ANDAs that refer to MEPRON (atovaquone) tablets, 250
mg, may be approved by the agency as long as they meet all relevant
legal and regulatory requirements for the approval of ANDAs.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9348 Filed 5-15-07; 8:45 am]
BILLING CODE 4160-01-S
