11488 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of NILSTAT 

(nystatin powder (oral, 100%)) 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was withdrawn from sale for reasons of 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 NILSTAT (nystatin 

powder (oral, 100%)) 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. ANDAs that refer 

to NILSTAT (nystatin powder (oral, 

100%)) may 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: February 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4595 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–2010–N–0318] 

Determination That MEGACE 

(Megestrol Acetate) Tablets and Nine 

Other Drug Products 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Withdrawn From Sale for Reasons of 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 the 10 drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(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 (the 

FD&C 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, a drug is 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 (21 

CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved; (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved; and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicants, FDA 

withdrew approval of NDA 18–101 for 

SYMMETREL (amantadine 

hydrochloride (HCl)) Tablets and ANDA 

84–935 for DEXEDRINE 

(dextroamphetamine sulfate) Tablets in 

the Federal Register of July 21, 2010 (75 

FR 42455).) 

Application No. Drug Applicant 

NDA 16–979 .............. MEGACE (megestrol acetate) Tablets, 20 milligrams (mg) 

and 40 mg.

Bristol Myers Squibb, P.O. Box 4000, Princeton, NJ 

08543–4000. 

NDA 17–911 .............. CLINORIL (sulindac) Tablet, 150 mg ................................... Merck Research Laboratories, Sumneytown Pike, West 

Point, PA 19486. 

NDA 18–101 .............. SYMMETREL (amantadine HCl) Tablet, 100 mg ................ Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds 

Ford, PA 19317. 

NDA 18–482 .............. PROCARDIA (nifedipine) Capsule, 20 mg .......................... Pfizer Inc., 235 East 42nd St., New York, NY 10017–5755. 

NDA 18–768 .............. VEPESID (etoposide) Injection, 20 mg/milliliter (mL) .......... Bristol Myers Squibb. 

NDA 20–262 .............. TAXOL (paclitaxel) Injection, 6 mg/mL ................................ Do. 

NDA 20–450 .............. CEREBYX (fosphenytoin sodium) Injection, Equivalent to 

(EQ) 50 mg phenytoin sodium/mL.

Parke Davis, 2800 Plymouth Rd., Ann Arbor, MI 48106– 

1047. 

NDA 50–527 .............. DURICEF (cefadroxil/cefadroxil hemihydrate) Oral Suspension, EQ 250 mg base/5mL and EQ 500 mg base/5 mL.Warner Chilcott, Inc., 100 Enterprise Dr., Suite 280, Rockaway, NJ 07866. 

ANDA 84–051 ............ DEXTROSTAT (dextroamphetamine sulfate) Tablets, 5 mg 

and 10 mg.

Shire Development, Inc., 725 Chesterbrook Blvd., Wayne, 

PA 19087. 


emcdonald on DSK2BSOYB1PROD with NOTICES
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