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37862 Federal Register / Vol. 70, No.

125 / Thursday, June 30, 2005 / Notices

II. Comments under an ANDA procedure. ANDA 30, 2002 (addressing a relisting request
Interested persons may submit to the sponsors must, with certain exceptions, for Diazepam Autoinjector)).
Division of Dockets Management (see show that the drug for which they are The agency has determined that
ADDRESSES) written or electronic seeking approval contains the same Pfizer’s ZYVOX (linezolid) tablets, 400
comments on the guidance at any time. active ingredient in the same strength mg, were not withdrawn from sale for
Submit a single copy of electronic and dosage form as the ‘‘listed drug,’’ reasons of safety or effectiveness. FDA
comments or two paper copies of any which is typically a version of the drug has reviewed its files for records
mailed comments, except that that was previously approved. Sponsors concerning the withdrawal of ZYVOX
individuals may submit one paper copy. of ANDAs do not have to repeat the (linezolid) tablets, 400 mg, from sale.
Comments are to be identified with the extensive clinical testing otherwise There is no indication that the decision
docket number found in brackets in the necessary to gain approval of a new not to market ZYVOX (linezolid) tablets,
heading of this document. The guidance drug application (NDA). The only 400 mg, commercially is a function of
and received comments may be seen in clinical data required in an ANDA are safety or effectiveness concerns, and the
the Division of Dockets Management data to show that the drug that is the petitioner has identified no data or
between 9 a.m. and 4 p.m., Monday subject of the ANDA is bioequivalent to information suggesting that ZYVOX
through Friday. the listed drug. (linezolid) tablets, 400 mg, pose a safety
The 1984 amendments include what risk. FDA has independently evaluated
III. Electronic Access is now section 505(j)(7) of the Federal relevant literature and data for possible
Persons with access to the Internet Food, Drug, and Cosmetic Act (21 U.S.C. concerns regarding the safety or
may obtain the document at http:// 355(j)(7)), which requires FDA to effectiveness of this drug product. FDA publish a list of all approved drugs. has found no information that would
default.htm, FDA publishes this list as part of the indicate that this product was
guidance/index.htm, or http:// ‘‘Approved Drug Products with withdrawn for reasons of safety or Therapeutic Equivalence Evaluations,’’ effectiveness.
which is generally known as the For the reasons outlined, FDA
Dated: June 22, 2005.
‘‘Orange Book.’’ Under FDA regulations, determines that Pfizer’s ZYVOX
Jeffrey Shuren,
drugs are withdrawn from the list if the (linezolid) tablets, 400 mg, were not
Assistant Commissioner for Policy. withdrawn from sale for reasons of
agency withdraws or suspends approval
[FR Doc. 05–12908 Filed 6–29–05; 8:45 am] safety or effectiveness. Accordingly, the
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA agency will continue to list ZYVOX
determines that the listed drug was (linezolid) tablets, 400 mg, in the
withdrawn from sale for reasons of ‘‘Discontinued Drug Product List’’
DEPARTMENT OF HEALTH AND section of the Orange Book. The
HUMAN SERVICES safety or effectiveness (§ 314.162 (21
CFR 314.162)). ‘‘Discontinued Drug Product List’’
Food and Drug Administration Under § 314.161(a)(1) (21 CFR delineates, among other items, drug
314.161(a)(1)), the agency must products that have been discontinued
[Docket No. 2004P–0295] determine whether a listed drug was from marketing for reasons other than
withdrawn from sale for reasons of safety or effectiveness. ANDAs that refer
Determination That ZYVOX (Linezolid) to ZYVOX (linezolid) tablets, 400 mg,
Tablets, 400 Milligrams, Were Not safety or effectiveness before an ANDA
that refers to that listed drug may be may be approved by the agency.
Withdrawn From Sale for Reasons of
Safety or Effectiveness approved. FDA may not approve an Dated: June 22, 2005.
ANDA that does not refer to a listed Jeffrey Shuren,
AGENCY: Food and Drug Administration, drug. Assistant Commissioner for Policy.
HHS. ZYVOX (linezolid) tablets, 400 mg, [FR Doc. 05–12909 Filed 6–29–05; 8:45 am]
ACTION: Notice. are the subject of approved NDA 21–130 BILLING CODE 4160–01–S
held by Pharmacia and Upjohn Co., a
SUMMARY: The Food and Drug subsidiary of Pfizer, Inc. ZYVOX
Administration (FDA) has determined (linezolid) tablets, 400 mg, are indicated
that ZYVOX (linezolid) tablets, 400 DEPARTMENT OF HEALTH AND
for the treatment of certain infections HUMAN SERVICES
milligrams (mg), were not withdrawn caused by susceptible strains of certain
from sale for reasons of safety or microorganisms. Food and Drug Administration
effectiveness. This determination will In a citizen petition dated July 9, 2004
allow FDA to approve abbreviated new (Docket No. 2004P–0295), submitted Research Review Subcommittee of the
drug applications (ANDAs) for linezolid under 21 CFR 10.30, Lachman Blood Products Advisory Committee;
tablets, 400 mg. Consultant Services, Inc., requested that Notice of Meeting
FOR FURTHER INFORMATION CONTACT: the agency determine, as described in
Nicole Mueller, Center for Drug AGENCY: Food and Drug Administration,
§ 314.161, whether ZYVOX (linezolid) HHS.
Evaluation and Research (HFD–7), Food tablets, 400 mg, were withdrawn from
and Drug Administration, 5600 Fishers ACTION: Notice.
sale for reasons of safety or
Lane, Rockville, MD 20857, 301–594– effectiveness. The holder of the NDA for This notice announces a forthcoming
2041. ZYVOX (linezolid) tablets never meeting of a subcommittee of a public
SUPPLEMENTARY INFORMATION: In 1984, marketed the 400 mg strength. In advisory committee of the Food and
Congress enacted the Drug Price previous instances, the agency has Drug Administration (FDA). At least one
Competition and Patent Term determined that, for purposes of portion of the meeting will be closed to
Restoration Act of 1984 (Public Law 98– §§ 314.161 and 314.162, never the public.
417) (the 1984 amendments), which marketing an approved drug product is Name of Subcommittee: Research
authorized the approval of duplicate equivalent to withdrawing the drug Review Subcommittee of the Blood
versions of drug products approved from sale (see 67 FR 79640, December Products Advisory Committee

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