38910 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie L. Begansky, 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, email: 

AADPAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). 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 at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: Agenda: 

The committees will discuss 

supplemental new drug application 

(sNDA) 021306, for BUTRANS 

(buprenorphine) transdermal system 

submitted by Purdue Pharma L.P., 

evaluating BUTRANS in pediatric 

patients ages 7 through 16 years for 

management of pain severe enough to 

require daily, around-the-clock, longterm opioid treatment and for which 

alternative treatment options are 

inadequate. The committees will be 

asked to discuss the findings of the 

clinical study of BUTRANS conducted 

in pediatric patients, and whether they 

support additional labeling. 

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 https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. All electronic 

and written submissions submitted to 

the docket (see ADDRESSES) on or before 

August 30, 2017, will be provided to the 

committees. Oral presentations from the 

public will be scheduled between 

approximately 10:15 a.m. and 11:15 a.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 August 22, 2017. 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 August 23, 2017. 

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 disabilities. 

If you require special accommodations 

due to a disability, please contact 

Stephanie L. Begansky 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 

https://www.fda.gov/ 

AdvisoryCommittees/ 

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: August 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17303 Filed 8–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–0495] 

Determination That CORDARONE 

(Amiodarone Hydrochloride) Tablets, 

200 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 or Agency) has 

determined that CORDARONE 

(amiodarone hydrochloride) tablets, 200 

milligrams (mg), 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 

this drug product, and it will allow FDA 

to continue to approve ANDAs that refer 

to the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Forde, Center for Drug 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 38911 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6213, 

Silver Spring, MD 20993–0002, 301– 

348–3035. 

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 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 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). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, are the 

subject of NDA 018972, held by Wyeth 

Pharmaceuticals, Inc. (a subsidiary of 

Pfizer, Inc.), and initially approved on 

December 24, 1985. CORDARONE is 

indicated for the treatment of the 

following documented, life-threatening 

recurrent ventricular arrhythmias when 

these have not responded to 

documented adequate doses of other 

available antiarrhythmics or when 

alternative agents could not be tolerated: 

(1) Recurrent ventricular fibrillation and 

(2) recurrent hemodynamically unstable 

ventricular tachycardia. 

In correspondence dated February 7, 

2017, Pfizer, Inc. notified FDA that 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, were 

being discontinued, and FDA moved the 

drug product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Lachman Consultant Services, Inc. 

submitted a citizen petition dated 

January 25, 2017 (Docket No. FDA– 

2017–P–0495), under 21 CFR 10.30, 

requesting that the Agency determine 

whether CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CORDARONE 

(amiodarone hydrochloride) tablets, 200 

mg, were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that this drug 

product was not withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list CORDARONE 

(amiodarone hydrochloride) tablets, 200 

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 approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product 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: August 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17302 Filed 8–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–3966] 

Upsher-Smith Laboratories, Inc.; 

Withdrawal of Approval of an 

Abbreviated New Drug Application for 

ZALEPLON 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of an abbreviated 

new drug application (ANDA) for 

ZALEPLON Capsules, 5 milligrams (mg) 

and 10 mg, held by Upsher-Smith 

Laboratories, Inc. (Upsher-Smith), 6701 

Evenstad Dr., Maple Grove, MN 55369. 

Upsher-Smith has voluntarily requested 

that approval of this application be 

withdrawn, and has waived its 

opportunity for a hearing. 

DATES: Effective August 16, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Stefanie Kraus, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6215, 

Silver Spring, MD 20993–0002, 301– 

796–9585. 

SUPPLEMENTARY INFORMATION: On June 6, 

2008, FDA approved ANDA 078706 for 

ZALEPLON Capsules, 5 mg and 10 mg, 

submitted by Upsher-Smith. According 

to annual reports Upsher-Smith filed 

with the Agency, Upsher-Smith stopped 

distributing these products by April 6, 

2010. In a letter dated August 9, 2011, 

FDA informed Upsher-Smith that it had 

concerns about the validity of 

bioequivalence data submitted with 

ANDA 078706 from studies conducted 

by a certain contract research 

organization, establishing 

bioequivalence of Upsher-Smith’s 

product to the reference listed drug, 

SONATA (ZALEPLON) Capsules, 5 mg 

and 10 mg. In that letter, FDA directed 

Upsher-Smith to supplement its ANDA 

with either: (1) New bioequivalence 

studies or (2) re-assays of the samples 

from the original bioequivalence 

studies. Upsher-Smith did not respond 

to this letter. FDA then sent another 

letter to Upsher-Smith on August 19, 


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