Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 27575 

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 http://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Were Not Withdrawn From Sale for 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. 

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milligrams (mg), were not withdrawn 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 (§ 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 

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 

protocols submitted to the agency to 

support anticancer effectiveness claims. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 


cprice-sewell on PROD1PC66 with NOTICES
27576 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1–

800–835–4709 or 301–827–1800. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rajeshwari Sridhara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 1210, 

Silver Spring, MD 20903–0002, 

301–796–2070; or 

Peter Bross, Center for Biologics 

Evaluation and Research (HFM–

755), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–5378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Clinical Trial Endpoints for the 

Approval of Cancer Drugs and 

Biologics.’’ FDA is developing guidance 

on oncology endpoints through a 

process that includes public workshops 

of oncology experts and discussions 

before FDA’s Oncologic Drugs Advisory 

Committee. This guidance provides 

background information and general 

principles. The endpoints discussed in 

this guidance are for drugs to treat 

patients with an existing cancer. This 

guidance does not address endpoints for 

drugs to prevent or decrease the 

incidence of cancer. 

The availability of a draft of this 

guidance was announced in the Federal 

Register of April 4, 2005 (70 FR 17095). 

Comments received from industry, 

professional societies, and consumer 

groups on the draft guidance have been 

taken into consideration by FDA in 

finalizing this guidance, and some of the 

changes are summarized here. The 

section on future methods for assessing 

progression has been clarified based on 

the comments received and FDA’s 

current thinking and practice. The 

section on no treatment or placebo 

control and the section on isolating drug 

effect in combination also have been 

clarified based on the comments 

received and FDA’s view that these do 

not directly concern the selection or 

evaluation of endpoints. Throughout the 

guidance document, the language has 

been condensed and simplified to be 

concise and clear. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on clinical trial 

endpoints for the approval of cancer 

drugs and biologics. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

21 CFR part 312 have been approved 

under 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under 0910–0001, and 

the collections of information referred to 

in the guidance for industry entitled 

‘‘Special Protocol Assessment’’ have 

been approved under 0910–0470. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9345 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0185] 

Draft Guidance for Industry and 

Review Staff on Labeling for Human 

Prescription Drugs—Determining 

Established Pharmacologic Class for 

Use in the Highlights of Prescribing 

Information; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and review staff entitled 

‘‘Labeling for Human Prescription 

Drugs—Determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information.’’

This guidance is intended to help 

applicants and the review staff in the 

Center for Drug Evaluation and Research 

(CDER) at FDA determine when a drug 

belongs to an established pharmacologic 

class as well as how to select the 

appropriate word or phrase (term) that 

describes the pharmacologic class for 

inclusion in the Indications and Usage 

section of Highlights of Prescribing 

Information (Highlights) of approved 

labeling. 

DATES: Submit written or electronic 

comments on the draft guidance by 

August 14, 2007. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 


cprice-sewell on PROD1PC66 with NOTICES