Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 55797 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants 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. 

ANDA applicants 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 known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed 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withdrawn from sale for reasons of 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 (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withdrawn from sale for reasons of 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. 

VESANOID (tretinoin) Capsules, 10 

mg, are the subject of NDA 20–438, held 

by Hoffman-La Roche Inc. (Roche), and 

initially approved on November 22, 

1995. VESANOID is indicated for the 

‘‘induction of remission in patients with 

acute promyelocytic leukemia (APL), 

French-American-British (FAB) 

classification M3 (including the M3 

variant), characterized by the presence 

of the t(15;17) translocation and/or the 

presence of the PML/RARa 

[promyelocytic leukemia/retinoic acid 

receptor alpha] gene who are refractory 

to, or who have relapsed from, 

anthracycline chemotherapy, or for 

whom anthracycline-based 

chemotherapy is contraindicated’’ 

(VESANOID labeling). 

In a letter dated December 2, 2009, 

Roche notified FDA that VESANOID 

(tretinoin) Capsules, 10 mg, were being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. There is one approved ANDA for 

tretinoin capsules, 10 mg (ANDA No. 

77–684); this drug product is listed in 

the Orange Book and, following the 

discontinuation of VESANOID, was 

designated as the reference listed drug 

to which new ANDAs should refer. 

Rakoczy Molino Mazzochi Siwik LLP 

submitted a citizen petition dated 

March 17, 2010 (Docket No. FDA–2010– 

P–0157), under 21 CFR 10.30, 

requesting that the agency determine 

whether VESANOID (tretinoin) 

Capsules, 10 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing agency records, FDA has 

determined under § 314.161 that 

VESANOID (tretinoin) Capsules, 10 mg, 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that VESANOID 

(tretinoin) Capsules, 10 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

VESANOID (tretinoin) Capsules, 10 mg, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events and have found no information 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the agency will continue 

to list VESANOID (tretinoin) Capsules, 

10 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. FDA 

will not begin procedures to withdraw 

approval of the approved ANDA that 

refers to VESANOID. Additional ANDAs 

for tretinoin capsules, 10 mg, may also 

be approved by the agency as long as 

they meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: September 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22807 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0462] 

Draft Guidance for Industry on Chronic 

Hepatitis C Virus Infection: Developing 

Direct-Acting Antiviral Agents for 

Treatment; 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 entitled ‘‘Chronic Hepatitis C 

Virus Infection: Developing DirectActing Antiviral Agents for Treatment.’’ 

The purpose of this guidance is to assist 

sponsors in all phases of development 

of direct-acting antiviral agents (DAAs), 

defined as agents that interfere with 

specific steps in the hepatitis C virus 

(HCV) replication cycle. The guidance 

outlines the types of nonclinical studies 

and clinical trials recommended 

throughout the drug development 

process to support approval of 

treatments for chronic hepatitis C 

(CHC), including in patients with 

compensated and decompensated 

cirrhosis and those co-infected with 

human immunodeficiency virus (HIV). 

The guidance also addresses preapproval access in the form of treatment 

investigational new drug applications 

(INDs) and intermediate-sized safety 

protocols. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 15, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 


jlentini on DSKJ8SOYB1PROD with NOTICES
55798 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Murray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6360, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Chronic Hepatitis C Virus Infection: 

Developing Direct-Acting Antiviral 

Agents for Treatment.’’ This draft 

guidance addresses nonclinical 

development, early phases of clinical 

development, phase 3 protocol designs, 

and endpoints for the treatment of CHC, 

including in patients who are treatment 

naı ̈ve or experienced, patients without 

cirrhosis, patients with compensated 

and decompensated cirrhosis, and 

patients co-infected with HCV and HIV. 

Important issues addressed in this 

guidance include: Drug development 

methods to reduce the emergence of 

drug resistance, types of trial designs to 

assess optimal dose and treatment 

duration, combination therapy with 

multiple investigational drugs, 

recommendations on development of 

drugs to meet unmet medical needs, and 

use of treatment INDs or other smaller 

safety protocols to provide early access 

of multiple DAAs for patients at risk of 

imminent progression of liver disease. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on developing DAAs for treatment of 

CHC virus infection. 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 that 

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 OMB control 

number 0910–0014, the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001, and the collections 

of information referred to in the 

guidance ‘‘Establishment and Operation 

of Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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 either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: September 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22806 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0455] 

North American Bioproducts 

Corporation; Filing of Food Additive 

Petition (Animal Use); Penicillin G 

Procaine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that North American Bioproducts Corp. 

has filed a petition proposing that the 

food additive regulations be amended to 

provide for the safe use of penicillin G 

procaine as an antimicrobial processing 

aid in fuel-ethanol fermentations with 

respect to its consequent presence in byproduct distiller grains used as an 

animal feed or feed ingredient. 

DATES: Submit either electronic or 

written comments on the petitioner’s 

environmental assessment by October 

14, 2010. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Isabel W. Pocurull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6853, 

email: isabel.pocurull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(section 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 2268) has been filed by 

North American Bioproducts Corp., 

Corporate Support Center, 1815 Satellite 

Blvd., Bldg. 200, Duluth, GA 30097. The 

petition proposes to amend the food 

additive regulations in part 573 Food 

Additives Permitted in Feed and 

Drinking Water of Animals (21 CFR part 

573) to provide for the safe use of 

penicillin G procaine as an 

antimicrobial processing aid in fuelethanol fermentations with respect to its 

consequent presence in by-product 

distiller grains used as an animal feed 

or feed ingredient. 

The potential environmental impact 

of this action is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see ADDRESSES) for public review and 

comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. It is 

only necessary to submit one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 


jlentini on DSKJ8SOYB1PROD with NOTICES