1516 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

(HCl), dopamine HCl, edetate calcium 

disodium, folic acid, glycopyrrolate, 

hydroxyzine HCl, ketorolac 

tromethamine, labetalol HCl, mannitol, 

metoclopramide HCl, moxifloxacin HCl, 

nalbuphine HCl, polidocanol, potassium 

acetate, procainamide HCl, sodium 

nitroprusside, sodium thiosulfate, and 

verapamil HCl. Interested persons were 

originally given until September 29, 

2020, to comment on FDA’s proposals. 

During the comment period for the 

July 31, 2020, notice, FDA received a 

request to allow interested persons 

additional time to comment. The 

requester asserted that the time period 

of 60 days was insufficient to respond 

fully to FDA’s specific requests for 

comments and noted the commenter’s 

obligations to respond to the exigencies 

of COVID–19 pandemic. 

FDA has considered the request and 

other relevant factors, and accordingly 

is reopening the comment period for the 

July 31, 2020, notice for 30 days, until 

February 8, 2021. The Agency believes 

that an additional 30 days will allow 

adequate time for interested persons to 

submit comments. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00123 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2300] 

Determination That ARALEN 

(Chloroquine Phosphate) Oral Tablets, 

500 Milligrams, 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Products Were Not Withdrawn From 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in this document were not withdrawn 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 known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is 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) (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 006002 ARALEN ................... Chloroquine Phosphate.500 milligrams (mg) ................... Tablet; Oral ............... Sanofi-Aventis U.S. 

LLC. 

NDA 006134 DOLOPHINE HYDROCHLORIDE.Methadone Hydrochloride.5 mg; 10 mg ............................... Tablet; Oral ............... Hikma Pharmaceuticals PLC. 

NDA 007409 BENTYL .................... Dicyclomine Hydrochloride.10 mg ......................................... Capsule; Oral ........... Allergan Pharmaceuticals. 

Dicyclomine Hydrochloride.20 mg ......................................... Tablet; Oral.

NDA 008085 Methotrexate Sodium Methotrexate Sodium Equivalent to (EQ) 2.5 mg Base Tablet; Oral ............... DAVA Pharmaceuticals, Inc. 

NDA 008678 Isoniazid ................... Isoniazid ................... 100 mg; 300 mg ......................... Tablet; Oral ............... Sandoz. 

NDA 012945 DIAMOX ................... Acetazolamide .......... 500 mg ....................................... Extended-Release 

Capsule; Oral.

Teva Branded Pharmaceutical Products. 

NDA 014103 ONCOVIN ................. Vincristine Sulfate ..... 1 mg/milliliter (mL); 1 mg/Vial; 5 

mg/Vial.

Injectable; Injection ... Eli Lilly and Co. 

NDA 016792 SURMONTIL ............ Trimipramine Maleate EQ 25 mg/Base; EQ 50 mg/ 

Base; EQ 100 mg/Base.

Capsule; Oral ........... Teva Women’s 

Health, Inc. 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1517 

Application 

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

NDA 016801 XYLOCAINE PRESERVATIVE FREE.Lidocaine Hydrochloride.1%; 2%; 4%; 10%; 20% ............ Injectable; Injection ... Fresenius Kabi USA, 

LLC. 

NDA 018238 MICRO–K ................. Potassium Chloride .. 8 milliequivalents (mEq); 10 

mEq.

Extended-Release 

Capsule; Oral.

Nesher Pharmaceuticals LLC. 

NDA 019568 DERMATOP ............. Prednicarbate ........... 0.10% ......................................... Ointment; Topical ..... Valeant Pharmaceuticals. 

NDA 020192 LAMISIL .................... Terbinafine Hydrochloride.1% .............................................. Cream; Topical ......... Novartis. 

NDA 020482 PRECOSE ................ Acarbose .................. 25 mg; 50 mg; 100 mg .............. Tablet; Oral ............... Bayer Healthcare. 

NDA 020591 TARKA ...................... Trandolapril; 

Verapamil Hydrochloride.

1 mg; 240 mg ............................. Extended-Release 

Tablet; Oral.

AbbVie Inc. 

NDA 020635 LEVAQUIN ............... Levofloxacin .............. EQ 500 mg/20 mL; EQ 750 mg/ 

30 mL.

Injectable; Injection ... Janssen Pharmaceuticals, Inc. 

NDA 020823 EXELON ................... Rivastigmine Tartrate EQ 1.5 mg Base; EQ 3 mg 

Base; EQ 4.5 mg Base; EQ 6 

mg Base.

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

NDA 020920 NATRECOR ............. Nesiritide ................... 1.5 mg/Vial ................................. For Solution; Intravenous.Scios Inc. 

NDA 021549 EMEND ..................... Aprepitant ................. 40 mg ......................................... Capsule; Oral ........... Merck. 

NDA 021590 FAZACLO ODT ........ Clozapine .................. 12.5 mg; 25 mg; 100 mg; 150 

mg; and 200 mg.

Orally Disintegrating 

Tablet; Oral.

Jazz Pharmaceuticals 

PLC. 

NDA 202535 PREPOPIK ............... Citric Acid, Magnesium Oxide, and 

Sodium Picosulfate.

12 grams (g)/Packet; 3.5 g/ 

Packet; 10 mg/Packet.

For Solution; Oral ..... Ferring Pharmaceuticals Inc. 

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: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00118 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Committee on the National Health 

Service Corps 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Committee on the National 

Health Service Corps (NACNHSC) will 

hold public meetings for the 2021 

calendar year (CY). Information about 

NACNHSC, agendas, and materials for 

these meetings can be found on the 

NACNHSC website at https://

nhsc.hrsa.gov/about/national-advisorycouncil-nhsc/index.html. 

DATES: NACNHSC meetings will be held 

on 

• March 16, 2021, 9:00 a.m.–5:00 p.m. 

Eastern Time (ET) and March 17, 2021, 

9:00 a.m.–2:00 p.m. ET; 

• June 22, 2021, 9:00 a.m.–5:00 p.m. 

ET and June 23, 2021, 9:00 a.m.–2:00 

p.m. ET; 

• November 9, 2021, 9:00 a.m.–5: 00 

p.m. ET and November 10, 2021, 9:00 

a.m.–2:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe 

Connect webinar. For updates on how 

the meeting will be held, visit the 

NACNHSC website 30 business days 

before the date of the meeting, where 

instructions for joining meetings either 

in-person or remotely will also be 

posted. In-person NACNHSC meetings 

will be held at 5600 Fishers Lane, 

Rockville, Maryland 20857. For meeting 

information updates, go to the 

NACNHSC website meeting page at 

https://nhsc.hrsa.gov/nac/ 

meetings.html. 

FOR FURTHER INFORMATION CONTACT: 

Diane Fabiyi-King (DFO), Division of 

National Health Service Corps, Bureau 

of Health Workforce, HRSA, 5600 

Fishers Lane, Rockville, Maryland 

20857; 301–443–3609; or 

NHSCAdvisoryCouncil@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

NACNHSC provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning the activities 

under Subpart II, Part D of Title III of 

the Public Health Service Act (42 U.S.C. 

254d–254k). NACNHSC designates areas 

of the United States with health 

professional shortages and assigns 

National Health Service Corps clinicians 

to improve the delivery of health 

services in health professional shortage 

areas. Since priorities dictate meeting 

times and agenda items, be advised that 

start times, end times, and agenda items 

are subject to change. For CY 2021 

meetings, agenda items may include, 

but are not limited to, the identification 

of NACNHSC priorities for future 


tkelley on DSKBCP9HB2PROD with NOTICES