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Federal Register / Vol. 72, No.

94 / Wednesday, May 16, 2007 / Notices 27575

OMB control number 0910–0599. The Food, Drug, and Cosmetic Act (the act) Drug Product List’’ section of the Orange
approval expires on May 31, 2010. A (21 U.S.C. 355(j)(7)), which requires Book. The ‘‘Discontinued Drug Product
copy of the supporting statement for this FDA to publish a list of all approved List’’ delineates, among other items,
information collection is available on drugs. FDA publishes this list as part of drug products that have been
the Internet at http://www.fda.gov/ the ‘‘Approved Drug Products With discontinued from marketing for reasons
ohrms/dockets. Therapeutic Equivalence Evaluations,’’ other than safety oreffectiveness.
Dated: May 10, 2007. which is generally known as the ANDAs that refer to MEPRON
‘‘Orange Book.’’ Under FDA regulations, (atovaquone) tablets, 250 mg, may be
Jeffrey Shuren,
drugs are withdrawn from the list if the approved by the agency as long as they
Assistant Commissioner for Policy.
agency withdraws or suspends approval meet all relevant legal and regulatory
[FR Doc. E7–9436 Filed 5–15–07; 8:45 am] of the drug’s NDA or ANDA for reasons requirements for the approval of
BILLING CODE 4160–01–S of safety or effectiveness or if FDA ANDAs.
determines that the listed drug was Dated: May 10, 2007.
withdrawn from sale for reasons of
DEPARTMENT OF HEALTH AND Jeffrey Shuren,
safety or effectiveness (§ 314.161(a)(1)
HUMAN SERVICES (21 CFR 314.162)). Assistant Commissioner for Policy.
Under § 314.161(a)(1) (21 CFR [FR Doc. E7–9348 Filed 5–15–07; 8:45 am]
Food and Drug Administration 314.161(a)(1)), the agency must BILLING CODE 4160–01–S
[Docket No. 2006P–0372] determine whether a listed drug was
withdrawn from sale for reasons of
Determination That MEPRON safety or effectiveness before an ANDA DEPARTMENT OF HEALTH AND
(Atovaquone) Tablets, 250 milligrams, that refers to that listed drug may be HUMAN SERVICES
Were Not Withdrawn From Sale for approved. FDA may not approve an
Reasons of Safety or Effectiveness ANDA that does not refer to a listed Food and Drug Administration

AGENCY: Food and Drug Administration, drug. [Docket No. 2005D–0112]


MEPRON (atovaquone) tablets, 250
HHS. Guidance for Industry on Clinical Trial
mg, are the subject of approved NDA
ACTION: Notice. 20–259 held by GlaxoSmithKline Endpoints for the Approval of Cancer
SUMMARY: The Food and Drug (Glaxo). MEPRON (atovaquone) tablets, Drugs and Biologics; Availability
Administration (FDA) has determined 250 mg, approved November 25, 1992, AGENCY: Food and Drug Administration,
that MEPRON (atovaquone) tablets, 250 are indicated for the prevention of HHS.
milligrams (mg), were not withdrawn Pneumocystis carinii pneumonia in
patients who are intolerant to ACTION: Notice.
from sale for reasons of safety or
effectiveness. This determination will trimethoprim-sulfamethoxazole (TMP- SUMMARY: The Food and Drug
allow FDA to approve abbreviated new SMX). Glaxo ceased marketing Administration (FDA) is announcing the
drug applications (ANDAs) for MEPRON (atovaquone) tablets, 250 mg, availability of a guidance for industry
atovaquone tablets, 250 mg. in 1995. entitled ‘‘Clinical Trial Endpoints for
Lachman Consultant Services, Inc., the Approval of Cancer Drugs and
FOR FURTHER INFORMATION CONTACT:
submitted a citizen petition dated Biologics.’’ This guidance provides
Christine F. Rogers, Center for Drug September 7, 2006 (Docket No. 2006P–
Evaluation and Research (HFD–7), Food recommendations to applicants on
0372/CP1), under 21 CFR 10.30, endpoints for cancer clinical trials
and Drug Administration, 5600 Fishers requesting that the agency determine, as
Lane, Rockville, MD 20857, 301–594– submitted to FDA to support
described in § 314.161, whether effectiveness claims in new drug
2041. MEPRON (atovaquone) tablets, 250 mg, applications, biologics license
SUPPLEMENTARY INFORMATION: In 1984, were withdrawn from sale for reasons of applications, or supplemental
Congress enacted the Drug Price safety or effectiveness.The agency has applications. Applicants are encouraged
Competition and Patent Term determined that Glaxo’s MEPRON to use this guidance to design cancer
Restoration Act of 1984 (Public Law 98– (atovaquone) tablets, 250 mg, were not clinical trials and to discuss protocols
417) (the 1984 amendments), which withdrawn from sale for reasons of
with the agency. This guidance provides
authorized the approval of duplicate safety or effectiveness. The petitioner
background information and discusses
versions of drug products approved has identified no data or other
general regulatory principles.
under an ANDA procedure. ANDA information suggesting that MEPRON
Additional companion guidances will
sponsors must, with certain exceptions, tablets, 250 mg, were withdrawn from
follow and will focus on endpoints for
show that the drug for which they are sale as a result of safety or effectiveness
specific cancer types (e.g., lung cancer,
seeking approval contains the same concerns. FDA has independently
colon cancer) to support drug approval
active ingredient in the same strength evaluated relevant literature and data
or labeling claims. This guidance, and
and dosage form as the ‘‘listed drug,’’ for adverse event reports and has found
the subsequent indication-specific
which is a version of the drug that was no information that would indicate this
guidances, should speed the
previously approved. Sponsors of product was withdrawn for reasons of
development and improve the quality of
ANDAs do not have to repeat the safety or effectiveness.
After considering the citizen petition protocols submitted to the agency to
extensive clinical testing otherwise
and reviewing its records, FDA support anticancer effectiveness claims.
necessary to gain approval of a new
determines that, for the reasons outlined DATES: Submit written or electronic
drug application (NDA). The only
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clinical data required in an ANDA are in this notice, Glaxo’s MEPRON comments on agency guidances at any
data to show that the drug that is the (atovaquone) tablets, 250 mg, were not time.
subject of the ANDA is bioequivalent to withdrawn from sale for reasons of ADDRESSES: Submit written requests for
the listed drug. safety or effectiveness. Accordingly, the single copies of this guidance to the
The 1984 amendments include what agency will list MEPRON (atovaquone) Division of Drug Information (HFD–
is now section 505(j)(7) of the Federal tablets, 250 mg, in the ‘‘Discontinued 240), Center for Drug Evaluation and

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27576 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices

Research, Food and Drug the comments received and FDA’s Dated: May 10, 2007.
Administration, 5600 Fishers Lane, current thinking and practice. The Jeffrey Shuren,
Rockville, MD 20857, or the Office of section on no treatment or placebo Assistant Commissioner for Policy.
Communication, Training, and control and the section on isolating drug [FR Doc. E7–9345 Filed 5–15–07; 8:45 am]
Manufacturers Assistance (HFM–40), effect in combination also have been BILLING CODE 4160–01–S
Center for Biologics Evaluation and clarified based on the comments
Research (CBER), Food and Drug received and FDA’s view that these do
Administration, 1401 Rockville Pike, not directly concern the selection or DEPARTMENT OF HEALTH AND
suite 200N, Rockville, MD 20852–1448. evaluation of endpoints. Throughout the HUMAN SERVICES
Send one self-addressed adhesive label guidance document, the language has
to assist that office in processing your been condensed and simplified to be Food and Drug Administration
requests. The guidance may also be concise and clear. [Docket No. 2007D–0185]
obtained by mail by calling CBER at 1– This guidance is being issued
800–835–4709 or 301–827–1800. consistent with FDA’s good guidance Draft Guidance for Industry and
Submit written comments on the practices regulation (21 CFR 10.115). Review Staff on Labeling for Human
guidance to the Division of Dockets The guidance represents the agency’s Prescription Drugs—Determining
Management (HFA–305), Food and Drug current thinking on clinical trial Established Pharmacologic Class for
Administration, 5630 Fishers Lane, rm. endpoints for the approval of cancer Use in the Highlights of Prescribing
1061, Rockville, MD 20852. Submit drugs and biologics. It does not create or Information; Availability
electronic comments to http:// confer any rights for or on any person
www.fda.gov/dockets/ecomments. See and does not operate to bind FDA or the AGENCY: Food and Drug Administration,
the SUPPLEMENTARY INFORMATION section public. An alternative approach may be HHS.
for electronic access to the guidance used if such approach satisfies the ACTION: Notice.
document. requirements of the applicable statutes
SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: and regulations.
Administration (FDA) is announcing the
Rajeshwari Sridhara, Center for Drug II. The Paperwork Reduction Act of availability of a draft guidance for
Evaluation and Research, Food and 1995 industry and review staff entitled
Drug Administration, 10903 New ‘‘Labeling for Human Prescription
Hampshire Ave., Bldg. 22, rm. 1210, This guidance refers to previously
Drugs—Determining Established
Silver Spring, MD 20903–0002, approved collections of information
Pharmacologic Class for Use in the
301–796–2070; or found in FDA regulations. These
Highlights of Prescribing Information.’’
Peter Bross, Center for Biologics collections of information are subject to
This guidance is intended to help
Evaluation and Research (HFM– review by the Office of Management and
applicants and the review staff in the
755), Food and Drug Budget (OMB) under the Paperwork
Center for Drug Evaluation and Research
Administration, 1401 Rockville Reduction Act of 1995 (44 U.S.C. 3501–
(CDER) at FDA determine when a drug
Pike, Rockville, MD 20852, 301– 3520). The collections of information in
belongs to an established pharmacologic
827–5378. 21 CFR part 312 have been approved
class as well as how to select the
SUPPLEMENTARY INFORMATION: under 0910–0014; the collections of
appropriate word or phrase (term) that
information in 21 CFR part 314 have
I. Background describes the pharmacologic class for
been approved under 0910–0001, and
inclusion in the Indications and Usage
FDA is announcing the availability of the collections of information referred to
section of Highlights of Prescribing
a guidance for industry entitled in the guidance for industry entitled
Information (Highlights) of approved
‘‘Clinical Trial Endpoints for the ‘‘Special Protocol Assessment’’ have
labeling.
Approval of Cancer Drugs and been approved under 0910–0470.
Biologics.’’ FDA is developing guidance DATES: Submit written or electronic
III. Comments comments on the draft guidance by
on oncology endpoints through a
process that includes public workshops Interested persons may submit to the August 14, 2007. General comments on
of oncology experts and discussions Division of Dockets Management (see agency guidance documents are
before FDA’s Oncologic Drugs Advisory ADDRESSES) written or electronic welcome at any time.
Committee. This guidance provides comments regarding this document. ADDRESSES: Submit written requests for
background information and general Submit a single copy of electronic single copies of the draft guidance to the
principles. The endpoints discussed in comments or two paper copies of any Division of Drug Information (HFD–
this guidance are for drugs to treat mailed comments, except that 240), Center for Drug Evaluation and
patients with an existing cancer. This individuals may submit one paper copy. Research, Food and Drug
guidance does not address endpoints for Comments are to be identified with the Administration, 5600 Fishers Lane,
drugs to prevent or decrease the docket number found in brackets in the Rockville, MD 20857. Send one self-
incidence of cancer. heading of this document. Received addressed adhesive label to assist that
The availability of a draft of this comments may be seen in the Division office in processing your requests.
guidance was announced in the Federal of Dockets Management between 9 a.m. Submit written comments on the draft
Register of April 4, 2005 (70 FR 17095). and 4 p.m., Monday through Friday. guidance to the Division of Dockets
Comments received from industry, Management (HFA–305), Food and Drug
IV. Electronic Access
professional societies, and consumer Administration, 5630 Fishers Lane, rm.
cprice-sewell on PROD1PC66 with NOTICES

groups on the draft guidance have been Persons with access to the Internet 1061, Rockville, MD 20852. Submit
taken into consideration by FDA in may obtain the document at http:// electronic comments to http://
finalizing this guidance, and some of the www.fda.gov/cder/guidance/index.htm, www.fda.gov/dockets/ecomments. See
changes are summarized here. The http://www.fda.gov/cber/ the SUPPLEMENTARY INFORMATION section
section on future methods for assessing guidelines.htm, or http://www.fda.gov/ for electronic access to the draft
progression has been clarified based on ohrms/dockets/default.htm. guidance document.

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