Determination That ZYVOX (Linezolid) Tablets, 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 37862 [05-12909]
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37862
Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Notices
II. Comments
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Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Submit a single copy of electronic
comments or two paper copies of any
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individuals may submit one paper copy.
Comments are to be identified with the
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and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/reading.htm.
Dated: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12908 Filed 6–29–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P–0295]
Determination That ZYVOX (Linezolid)
Tablets, 400 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Withdrawn From Sale for Reasons of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 ZYVOX (linezolid) tablets, 400
milligrams (mg), were not withdrawn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 linezolid
tablets, 400 mg.
FOR FURTHER INFORMATION CONTACT:
Nicole Mueller, 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
SUMMARY:
VerDate jul<14>2003
16:26 Jun 29, 2005
Jkt 205001
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 typically 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 (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 (§ 314.162 (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.
ZYVOX (linezolid) tablets, 400 mg,
are the subject of approved NDA 21–130
held by Pharmacia and Upjohn Co., a
subsidiary of Pfizer, Inc. ZYVOX
(linezolid) tablets, 400 mg, are indicated
for the treatment of certain infections
caused by susceptible strains of certain
microorganisms.
In a citizen petition dated July 9, 2004
(Docket No. 2004P–0295), submitted
under 21 CFR 10.30, Lachman
Consultant Services, Inc., requested that
the agency determine, as described in
§ 314.161, whether ZYVOX (linezolid)
tablets, 400 mg, were withdrawn from
sale for reasons of safety or
effectiveness. The holder of the NDA for
ZYVOX (linezolid) tablets never
marketed the 400 mg strength. In
previous instances, 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 (see 67 FR 79640, December
PO 00000
Frm 00118
Fmt 4703
Sfmt 4703
30, 2002 (addressing a relisting request
for Diazepam Autoinjector)).
The agency has determined that
Pfizer’s ZYVOX (linezolid) tablets, 400
mg, were not withdrawn from sale for
reasons of safety or effectiveness. FDA
has reviewed its files for records
concerning the withdrawal of ZYVOX
(linezolid) tablets, 400 mg, from sale.
There is no indication that the decision
not to market ZYVOX (linezolid) tablets,
400 mg, commercially is a function of
safety or effectiveness concerns, and the
petitioner has identified no data or
information suggesting that ZYVOX
(linezolid) tablets, 400 mg, pose a safety
risk. FDA has independently evaluated
relevant literature and data for possible
concerns regarding the safety or
effectiveness of this drug product. FDA
has found no information that would
indicate that this product was
withdrawn for reasons of safety or
effectiveness.
For the reasons outlined, FDA
determines that Pfizer’s ZYVOX
(linezolid) tablets, 400 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list ZYVOX
(linezolid) tablets, 400 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 ZYVOX (linezolid) tablets, 400 mg,
may be approved by the agency.
Dated: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12909 Filed 6–29–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Research Review Subcommittee of the
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a subcommittee of a public
advisory committee of the Food and
Drug Administration (FDA). At least one
portion of the meeting will be closed to
the public.
Name of Subcommittee: Research
Review Subcommittee of the Blood
Products Advisory Committee
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Page 37862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12909]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P-0295]
Determination That ZYVOX (Linezolid) Tablets, 400 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
ZYVOX (linezolid) tablets, 400 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
linezolid tablets, 400 mg.
FOR FURTHER INFORMATION CONTACT: Nicole Mueller, 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
typically 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 (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. 314.162 (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.
ZYVOX (linezolid) tablets, 400 mg, are the subject of approved NDA
21-130 held by Pharmacia and Upjohn Co., a subsidiary of Pfizer, Inc.
ZYVOX (linezolid) tablets, 400 mg, are indicated for the treatment of
certain infections caused by susceptible strains of certain
microorganisms.
In a citizen petition dated July 9, 2004 (Docket No. 2004P-0295),
submitted under 21 CFR 10.30, Lachman Consultant Services, Inc.,
requested that the agency determine, as described in Sec. 314.161,
whether ZYVOX (linezolid) tablets, 400 mg, were withdrawn from sale for
reasons of safety or effectiveness. The holder of the NDA for ZYVOX
(linezolid) tablets never marketed the 400 mg strength. In previous
instances, the agency has determined that, for purposes of Sec. Sec.
314.161 and 314.162, never marketing an approved drug product is
equivalent to withdrawing the drug from sale (see 67 FR 79640, December
30, 2002 (addressing a relisting request for Diazepam Autoinjector)).
The agency has determined that Pfizer's ZYVOX (linezolid) tablets,
400 mg, were not withdrawn from sale for reasons of safety or
effectiveness. FDA has reviewed its files for records concerning the
withdrawal of ZYVOX (linezolid) tablets, 400 mg, from sale. There is no
indication that the decision not to market ZYVOX (linezolid) tablets,
400 mg, commercially is a function of safety or effectiveness concerns,
and the petitioner has identified no data or information suggesting
that ZYVOX (linezolid) tablets, 400 mg, pose a safety risk. FDA has
independently evaluated relevant literature and data for possible
concerns regarding the safety or effectiveness of this drug product.
FDA has found no information that would indicate that this product was
withdrawn for reasons of safety or effectiveness.
For the reasons outlined, FDA determines that Pfizer's ZYVOX
(linezolid) tablets, 400 mg, were not withdrawn from sale for reasons
of safety or effectiveness. Accordingly, the agency will continue to
list ZYVOX (linezolid) tablets, 400 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 ZYVOX (linezolid) tablets, 400 mg,
may be approved by the agency.
Dated: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12909 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S
