76018 Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 

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 (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was withdrawn from sale for reasons of 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withdrawn from sale for reasons of 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. 

GLEEVEC (imatinib mesylate) 

Capsules, 50 mg and 100 mg, are the 

subject of NDA 21–335, held by 

Novartis Pharmaceutical Corp., and 

initially approved on May 10, 2001. 

GLEEVEC is a protein-tyrosine kinase 

inhibitor used in the treatment of a 

variety of malignancies, including Ph+ 

chronic myeloid leukemia and acute 

lymphoblastic leukemia, 

myelodysplastic/myeloproliferative 

diseases, aggressive systemic 

mastocytosis, hypereosinophilic 

syndrome, chronic eosinophilic 

leukemia, dermatofibrosarcoma 

protuberans, and gastrointestinal 

stromal tumors. FDA has moved 

GLEEVEC (imatinib mesylate) Capsules, 

50 mg and 100 mg, to the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Hyman, Phelps & McNamara, PC, 

submitted a citizen petition dated June 

3, 2010 (Docket No. FDA–2010–P– 

0275), under 21 CFR 10.30, requesting 

that the Agency determine whether 

GLEEVEC (imatinib mesylate) Capsules, 

50 mg and 100 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 

GLEEVEC (imatinib mesylate) Capsules, 

50 mg and 100 mg were not withdrawn 

for reasons of safety or effectiveness. 

The petitioner has identified no data or 

other information suggesting that 

GLEEVEC (imatinib mesylate) Capsules, 

50 mg and 100 mg, were withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

GLEEVEC (imatinib mesylate) capsules, 

50 mg and 100 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 these products were 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list GLEEVEC (imatinib 

mesylate) Capsules, 50 mg and 100 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. ANDAs that refer 

to GLEEVEC (imatinib mesylate) 

Capsules, 50 mg and 100 mg, 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 these drug products should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30570 Filed 12–6–10; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Third Annual Sentinel Initiative Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop: Third Annual 

Sentinel Initiative Public Workshop. 

Hosted by the Engelberg Center for 

Health Care Reform at The Brookings 

Institution, this 1-day public workshop 

will bring together the stakeholder 

community for a productive discussion 

on a variety of topics in active medical 

product surveillance, including an 

update on Mini-Sentinel and related 

activities, near-term plans for FDA’s 

Sentinel Initiative, and opportunities for 

coordination with other U.S. 

Department of Health and Human 

Services efforts that use distributed 

systems of automated health care data. 

Date and Time: The public workshop 

will be held on January 12, 2011, from 

8:30 a.m. to 4:30 p.m. 

Location: The public workshop will 

be held at the Renaissance Dupont 

Hotel, 1143 New Hampshire Ave. NW., 

Washington, DC 20037. 

Contact: Kayla Garvin, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6331, 

Silver Spring, MD 20993, 301–796– 

7578, e-mail: 

sentinelinitiative@fda.hhs.gov. 

Registration: To attend the public 

workshop, please register at http:// 

guest.cvent.com/d/hdq5r4/1Q. When 

registering, provide the following 

information: Your name, title, company 

or organization (if applicable), address, 

phone number, and e-mail address. 

There is no fee to register for the public 

workshop, but because seating is 

limited, registration will be on a firstcome, first-served basis. A 1-hour lunch 

break is scheduled; however, food will 

not be provided. There are multiple 

restaurants within walking distance of 

the hotel where attendees can get food. 

If you need special accommodations 

due to a disability, please contact The 

Brookings Institution event coordinator 

at 202–797–4391 or e-mail: 

sentinelevent@brookings.edu at least 7 

days in advance. 

Meeting Materials: Please be advised 

that as soon as workshop materials are 

available, they will be accessible at The 

Brookings Institution events Web site at 

http://www.brookings.edu//health/ 

events. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30562 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 


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