Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 11489 

Application No. Drug Applicant 

ANDA 84–935 ............ DEXEDRINE (dextroamphetamine sulfate) Tablet, 5 mg .... GlaxoSmithKline, 5 Moore Dr., P.O. Box 13398, Research 

Triangle Park, NC 27709–3398. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the Agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs listed in this document are 

unaffected by the discontinued 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the Agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines the 

labeling for these drug products should 

be revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: February 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4594 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Oncologic Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 12, 2011, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings.’’ 

Please note that visitors to the White 

Oak Campus must enter through 

Building 1. 

Contact Person: Caleb Briggs, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, e-mail: 

caleb.briggs@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On April 12, 2011, during 

the morning session, the committee will 

discuss supplemental new drug 

application (sNDA) 022334/S–009, trade 

name AFINITOR (everolimus) tablets, 

application submitted by Novartis 

Pharmaceuticals Corp. The proposed 

indication (use) for this product is for 

the treatment of patients with advanced 

neuroendocrine tumors (NET) of 

gastrointestinal, lung, or pancreatic 

origin. 

During the afternoon session, the 

committee will discuss sNDA 021938/ 

S–013, trade name SUTENT (sunitinib 

malate) capsules, application submitted 

by C.P. Pharmaceuticals International 

C.V., represented by Pfizer, Inc. 

(authorized U.S. agent). The proposed 

indication (use) for this product is for 

the treatment of unresectable pancreatic 

neuroendocrine tumors (PNET). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 29, 2011. 

Oral presentations from the public will 

be scheduled between approximately 

10:30 a.m. to 11 a.m. and 3:30 p.m. to 

4 p.m. Those individuals interested in 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 21, 2011. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 22, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caleb Briggs 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 


emcdonald on DSK2BSOYB1PROD with NOTICES
11490 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 24, 2011. 

Thinh Nguyen, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–4614 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0033] 

Withdrawal of Approval of New Animal 

Drug Applications; Phenylbutazone; 

Pyrantel; Tylosin; Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of eight new animal drug 

applications (NADAs). In a final rule 

published elsewhere in this issue of the 

Federal Register, FDA is amending the 

regulations to remove portions reflecting 

approval of these NADAs. 

DATES: Withdrawal of approval is 

effective March 14, 2011. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

sponsors in table 1 have requested that 

FDA withdraw approval of the three 

NADAs listed because the products are 

no longer manufactured or marketed. 

TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL (WOA) OF THREE NADAS

Sponsor 

NADA No. 

product 

(established name of drug) 

21 CFR Section 

affected 

(sponsor drug 

labeler code) 

First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 .......... NADA 48–647, Phenylbutazone boluses (phenylbutazone) .... 520.1720a 

(058829). 

Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247 ............ NADA 96–161, Hy-Con TYLAN Premix (tylosin phosphate) ... 558.625

(035369). 

Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des Moines, IA 50322 ... NADA 119–062, Cadco-BN–10 BANMINTH Premix (pyrantel 

tartrate).

558.485 

(011490). 

Truow Nutrition, Inc., 1590 Todd 

Farm Dr., Elgin, IL 60123 (Truow), has 

informed FDA that it is the sponsor of 

five feed premix NADAs previously 

owned by milling companies, which it 

purchased. NADA 100–352 was owned 

by NutriBasics Co., last doing business 

at P.O. Box 1014, Willmar, MN 56201. 

NADA 107–002 and NADA 123–000 

were owned by Seeco, Inc., also last 

doing business at P.O. Box 1014, 

Willmar, MN 56201. NADA 133–833 

and NADA 135–243 were owned by 

Southern Micro-Blenders, Inc., last 

doing business at 3801 North 

Hawthorne St., Chattanooga, TN 37406. 

Truow has requested that FDA 

withdraw approval of the five NADAs in 

table 2 because they are no longer 

manufactured or marketed. 

TABLE 2—VOLUNTARY REQUESTS FOR WOA OF FIVE NADAS BY TRUOW NUTRITION, INC. 

Previous sponsor NADA No., product 

(established name of drug) 

21 CFR section 

affected 

(sponsor drug 

labeler code) 

NutriBasics Co., North Highway 71, P.O. Box 1014, 

Willmar, MN 56201.

NADA 100–352, Seeco T–10 Premix (tylosin phosphate) .... 558.625 (053740). 

Seeco, Inc., P.O. Box 1014, North Highway 71, Willmar, 

MN 56201.

NADA 107–002, Seeco TYLAN–Sulfa 10 Premix (tylosin 

phosphate and sulfamethazine).

Not codified. 

Seeco, Inc., P.O. Box 1014, North Highway 71, Willmar, 

MN 56201.

NADA 123–000, Super Swine Wormer B–9 BANMINTH 

(pyrantel tartrate).

558.485 (011749). 

Southern Micro-Blenders, Inc., 3801 North Hawthorne St., 

Chattanooga, TN 37406.

NADA 133–833, TYLAN 10 Premix (tylosin phosphate) ...... 558.625 (049685). 

Southern Micro-Blenders, Inc., 3801 North Hawthorne St., 

Chattanooga, TN 37406.

NADA 135–243, Swine Guard-BN BANMINTH Premix 

(pyrantel tartrate).

558.485 (049685). 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

and redelegated to the Center for 

Veterinary Medicine, and in accordance 

with § 514.116 Notice of withdrawal of 

approval of application (21 CFR 

514.116), notice is given that approval 

of NADAs 48–647, 96–161, 100–352, 

107–002, 119–062, 123–000, 133–833, 

and 135–243, and all supplements and 

amendments thereto, is hereby 

withdrawn, effective March 14, 2011. 

In a final rule published elsewhere in 

this issue of the Federal Register, FDA 

is amending the animal drug regulations 

to reflect the withdrawal of approval of 

these NADAs. 

Dated: February 18, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–4545 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 


emcdonald on DSK2BSOYB1PROD with NOTICES