43388 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3137] 

Advisory Committee; Nonprescription 

Drugs Advisory Committee, Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Nonprescription Drugs 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Nonprescription 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until August 27, 2019. 

DATES: Authority for the 

Nonprescription Drugs Advisory 

Committee will expire on August 27, 

2017, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Moon Hee Choi, 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, email: NDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Nonprescription Drugs Advisory 

Committee (Committee). The Committee 

is a discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety and 

effectiveness of over-the-counter 

(nonprescription) human drug products, 

or any other FDA-regulated product, for 

use in the treatment of a broad spectrum 

of human symptoms and diseases and 

advises the Commissioner either on the 

issuance of monographs establishing 

conditions under which these drugs are 

generally recognized as safe and 

effective and not misbranded or on the 

approval of new drug applications for 

such drugs. The Committee serves as a 

forum for the exchange of views 

regarding the prescription and 

nonprescription status, including 

switches from one status to another, of 

these various drug products and 

combinations thereof. The Committee 

may also conduct peer review of Agency 

sponsored intramural and extramural 

scientific biomedical programs in 

support of FDA’s mission and regulatory 

responsibilities. 

The Committee shall consist of a core 

of 10 voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of internal 

medicine, family practice, clinical 

toxicology, clinical pharmacology, 

pharmacy, dentistry, and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Almost all non-Federal members 

of this committee serve as Special 

Government Employees. The core of 

voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting member who is 

identified with industry interests. 

Further information regarding the 

most recent charter and other 

information can be found at http://

www.fda.gov/AdvisoryCommittees/

CommitteesMeetingMaterials/ 

Drugs/Nonprescription

DrugsAdvisoryCommittee/default.htm 

or by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at http://www.fda.gov/

AdvisoryCommittees/default.htm. 

Dated: September 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19670 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4758] 

Determination That CORTONE 

(Cortisone Acetate) Tablets and 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 or Agency) has 

determined that the 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: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

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 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 generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

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Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43389 

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 safety or 

effectiveness reasons, 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 are no longer 

being marketed. 

Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant 

NDA 007750 .......... CORTONE ........................... Cortisone Acetate ....... 25 milligrams (mg) ............... Tablet; Oral ................. Merck & Co., Inc. 

NDA 008662 .......... NYDRAZID ........................... Isoniazid ...................... 100 mg/milliliter (mL) ............ Injectable; Injection ..... Sandoz Canada Inc. 

NDA 010571 .......... COMPAZINE ........................ Prochlorperazine Maleate.Equivalent to (EQ) 5 mg 

Base; EQ 10 mg Base; 

EQ 25 mg Base.

Tablet; Oral ................. SmithKline Beecham Corporation d/b/a 

GlaxoSmithKline. 

NDA 010670 .......... ORINASE ............................. Tolbutamide ................ 250 mg; 500 mg ................... Tablet; Oral ................. Pharmacia and Upjohn Co. 

NDA 011127 .......... COMPAZINE ........................ Prochlorperazine ......... 2.5 mg; 5 mg; 25 mg ........... Suppository; Rectal ..... SmithKline Beecham Corporation d/b/a 

GlaxoSmithKline. 

NDA 011808 .......... MELLARIL ............................ Thioridazine Hydrochloride (HCl).30 mg/mL; 100 mg/mL ......... Concentrate; Oral ....... Novartis Pharmaceuticals 

Corp. 

NDA 012145 .......... PROLIXIN ............................. Fluphenazine HCl ....... 2.5 mg/5 mL ......................... Elixir; Oral ................... Apothecon Inc., Division of 

Bristol Myers Squibb. 

NDA 014713 .......... ETRAFON 2–10; ETRAFON 

2–25; ETRAFON–A; 

ETRAFON–FORTE.

Perphenazine; 

Amitriptyline HCl.

2 mg/10 mg; 2 mg/25 mg; 4 

mg/10 mg; 4 mg/25 mg.

Tablet; Oral ................. Schering Corp. 

NDA 014715 .......... TRIAVIL 2–10; TRIAVIL 2– 

25; TRIAVIL 4–10; 

TRIAVIL 4–25; TRIAVIL 

4–50.

Perphenazine; 

Amitriptyline HCl.

2 mg/10 mg; 2 mg/25 mg; 4 

mg/10 mg; 4 mg/25 mg; 4 

mg/50 mg.

Tablet; Oral ................. New River Pharmaceuticals 

Inc. 

NDA 015539 .......... SERAX ................................. Oxazepam ................... 10 mg; 15 mg; 30 mg; 15 

mg.

Capsule; Oral ..............

Tablet; Oral .................

Alpharma U.S. Pharmaceuticals Division. 

NDA 015922 .......... HALDOL ............................... Haloperidol Lactate ..... EQ 2 mg Base/mL ............... Concentrate; Oral ....... Ortho-McNeil Pharmaceutical. 

NDA 016584 .......... NAVANE ............................... Thiothixene ................. 1 mg; 2 mg; 5 mg; 10 mg; 

20 mg.

Capsule; Oral .............. Pfizer Inc. 

NDA 016721 .......... DALMANE ............................ Flurazepam HCl .......... 15 mg; 30 mg ....................... Capsule; Oral .............. Valeant Pharmaceuticals 

International. 

NDA 017923 .......... MELLARIL–S ........................ Thioridazine ................ EQ 25 mg HCl/5 mL; EQ 

100 mg HCl/5mL.

Suspension; Oral ........ Novartis Pharmaceuticals 

Corp. 

NDA 018374 .......... BACTRIM ............................. Sulfamethoxazole; 

Trimethoprim.

80 mg/mL; 16 mg/mL ........... Injectable; Injection ..... Sun Pharmaceutical Industries, Inc. 

NDA 018485 .......... ISOPTIN ............................... Verapamil HCl ............. 2.5 mg/mL ............................ Injectable; Injection ..... Mt. Adams Technologies 

LLC. 

NDA 018596 .......... INTAL ................................... Cromolyn Sodium ....... 10 mg/mL ............................. Solution; Inhalation ..... King Pharmaceuticals LLC. 

NDA 018644 .......... WELLBUTRIN ...................... Bupropion HCl ............ 50 mg; 75 mg; 100 mg ........ Tablet; Oral ................. GlaxoSmithKline LLC. 

NDA 019287 .......... DIZAC ................................... Diazepam .................... 5 mg/mL ............................... Injectable; Injection ..... Pharmacia and Upjohn Co. 

NDA 019982 .......... ZEBETA ............................... Bisoprolol Fumarate .... 5 mg; 10 mg ......................... Tablet; Oral ................. Teva Branded Pharmaceutical Products R&D, 

Inc. 

NDA 020007 .......... ZOFRAN; ZOFRAN PRESERVATIVE FREE.Ondansetron HCl ........ EQ 2 mg Base/mL ............... Injectable; Injection ..... Novartis Pharmaceuticals 

Corp. 

NDA 020205 .......... PSORCON ........................... Diflorasone Diacetate 0.05% ................................... Cream; Topical ........... Taro Pharmaceuticals North 

America Inc. 

NDA 020947 .......... PENNSAID ........................... Diclofenac Sodium ...... 1.5% ..................................... Solution; Topical ......... Nuvo Pharmaceuticals Inc. 

NDA 021575 .......... FOSAMAX ............................ Alendronate Sodium ... EQ 70 mg Base/75 mL ........ Solution; Oral .............. Merck Sharp & Dohme 

Corp., a subsidiary of 

Merck & Co., Inc. 

NDA 050542 .......... AMOXIL ................................ Amoxicillin ................... 125 mg; 250 mg ................... Chewable Tablet; Oral Dr. Reddy’s Laboratories, 

Inc. 

NDA 050564 .......... AUGMENTIN ‘250’; 

AUGMENTIN ‘500‘.

Amoxicillin; 

Clavulanate Potassium.

250 mg/EQ 125 mg Base; 

500 mg/EQ 125 mg Base.

Tablet; Oral ................. Do. 

NDA 050581 .......... MEFOXIN IN SODIUM 

CHLORIDE 0.9% IN 

PLASTIC CONTAINER; 

MEFOXIN IN DEXTROSE 

5% IN PLASTIC CONTAINER.

Cefoxitin Sodium ......... EQ 20 mg Base/mL; EQ 40 

mg Base/mL; EQ 20 mg 

Base/mL; EQ 40 mg Base/ 

mL.

Injectable; Injection ..... Merck & Co., Inc. 

NDA 050591 .......... BACTROBAN ....................... Mupirocin .................... 2% ........................................ Ointment; Topical ........ SmithKline Beecham (Cork) 

Ltd., Ireland. 

NDA 050594 .......... ERYCETTE .......................... Erythromycin ............... 2% ........................................ Swab; Topical ............. Johnson & Johnson Consumer Inc. 

NDA 050754 .......... AMOXIL ................................ Amoxicillin ................... 500 mg; 875 mg ................... Tablet; Oral ................. Dr. Reddy’s Laboratories, 

Inc. 

NDA 050760 .......... AMOXIL ................................ Amoxicillin ................... 200 mg/5 mL; 400 mg/5 mL For Suspension; Oral .. Do. 

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43390 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list the drug 

products 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 and ANDAs listed are unaffected 

by the discontinued marketing of the 

products subject to those NDAs and 

ANDAs. 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 that labeling for these 

drug products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: September 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19611 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–4886] 

Utilizing Animal Studies To Evaluate 

Organ Preservation Devices; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Utilizing Animal 

Studies to Evaluate Organ Preservation 

Devices.’’ The intent of this draft 

guidance is to provide 

recommendations regarding best 

practices for utilizing animal studies for 

the evaluation of organ preservation 

devices. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–4886 for ‘‘Utilizing Animal 

Studies to Evaluate Organ Preservation 

Devices.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). An electronic copy of the 

guidance document is available for 

download from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Utilizing Animal 

Studies to Evaluate Organ Preservation 

Devices’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Kunkoski, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1504, Silver Spring, 

MD 20993–0002, 301–796–6439. 

SUPPLEMENTARY INFORMATION: 

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