Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4081 

use of immunizing agents. In addition, 

under 42 U.S.C. 1396s, the committee is 

mandated to establish and periodically 

review and, as appropriate, revise the 

list of vaccines for administration to 

vaccine-eligible children through the 

Vaccines for Children (VFC) program, 

along with schedules regarding dosing 

interval, dosage, and contraindications 

to administration of vaccines. Further, 

under provisions of the Affordable Care 

Act, section 2713 of the Public Health 

Service Act, immunization 

recommendations of the ACIP that have 

been approved by the Director of the 

Centers for Disease Control and 

Prevention and appear on CDC 

immunization schedules must be 

covered by applicable health plans. 

Matters to be Considered: The agenda 

will include discussions on COVID–19 

vaccines. No recommendation vote is 

scheduled for COVID–19 vaccines. 

Agenda items are subject to change as 

priorities dictate. For more information 

on the meeting agenda visit https://

www.cdc.gov/vaccines/acip/meetings/ 

meetings-info.html. 

Meeting Information: The meeting 

will be webcast live via the World Wide 

Web; for more information on ACIP 

please visit the ACIP website: http://

www.cdc.gov/vaccines/acip/index.html. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials are part of 

the public record and are subject to 

public disclosure. Do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

CDC does not accept comment by email. 

Written Public Comment: Written 

comments must be received on or before 

January 27, 2021. Oral Public Comment: 

This meeting will include time for 

members of the public to make an oral 

comment. Oral public comment will 

occur before any scheduled votes 

including all votes relevant to the 

ACIP’s Affordable Care Act and 

Vaccines for Children Program roles. 

Priority will be given to individuals 

who submit a request to make an oral 

public comment before the meeting 

according to the procedures below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the January 27, 2021 

ACIP meeting must submit a request at 

http://www.cdc.gov/vaccines/acip/ 

meetings/ no later than 11:59 p.m., EST, 

January 25, 2021 according to the 

instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

by January 26, 2021. To accommodate 

the significant interest in participation 

in the oral public comment session of 

ACIP meetings, each speaker will be 

limited to 3 minutes, and each speaker 

may only speak once per meeting. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–00870 Filed 1–12–21; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2306] 

TG United Inc., et al.; Withdrawal of 

Approval of 27 Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 27 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

February 16, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040083 ................................. Phentermine Hydrochloride (HCl) Capsules, 30 milligrams (mg) ......... TG United Inc., 16275 Aviation 

Loop Dr., Brooksville, FL 34604. 

ANDA 040451 ................................. Cyanocobalamin Injection, 1 mg/milliliters (mL) .................................... Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. 

ANDA 040518 ................................. Bethanechol Chloride Tablets, 50 mg ................................................... Morton Grove Pharmaceuticals 

Inc./Wockhardt USA LLC, 6451 

W. Main St., Morton Grove, IL 

60053. 

ANDA 040532 ................................. Bethanechol Chloride Tablets, 5 mg ..................................................... Do. 

4082 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

Application No. Drug Applicant 

ANDA 060347 ................................. Tetracycline HCl Capsules, 250 mg ...................................................... Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc., 235 East 

42nd St., New York, NY 10017. 

ANDA 060478 ................................. Neomycin Sulfate Ophthalmic Ointment ............................................... Pfizer Inc., 235 East 42nd St., 

New York, NY 10017. 

ANDA 065266 ................................. Clarithromycin Tablets, 250 mg and 500 mg ........................................ Morton Grove Pharmaceuticals 

Inc./Wockhardt USA LLC. 

ANDA 065281 ................................. Doxycycline Hyclate Delayed Release Capsules, Equivalent to (EQ) 

75 mg base; EQ 100 mg base.

Bausch Health US, LLC, 400 

Somerset Corporate Blvd., 

Bridgewater, NJ 08807. 

ANDA 075208 ................................. Ranitidine HCl Tablets, EQ 150 mg base; EQ 300 mg base ............... Morton Grove Pharmaceuticals 

Inc./Wockhardt USA LLC. 

ANDA 075822 ................................. Loratadine Orally Disintegrating Tablets, 10 mg ................................... GlaxoSmithKline Consumer 

Healthcare Holdings (US) LLC, 

184 Liberty Corner Rd., Suite 

200, Warren, NJ 07059. 

ANDA 076760 ................................. Ranitidine HCl Tablets, EQ 75 mg base ............................................... Morton Grove Pharmaceuticals 

Inc./Wockhardt USA LLC. 

ANDA 076849 ................................. Vinorelbine Tartrate Injection, EQ 10 mg base/mL ............................... Fresenius Kabi USA, LLC, Three 

Corporate Dr., Lake Zurich, IL 

60047. 

ANDA 077432 ................................. Carboplatin Injection, 50 mg/5 mL(10 mg/mL), 150 mg/15 mL (10 mg/ 

mL), and 450 mg/45 mL (10 mg/mL).

Do. 

ANDA 078500 ................................. Amlodipine Besylate Tablets, EQ 2.5 mg base; EQ 5 mg base; EQ 

10 mg base.

Morton Grove Pharmaceuticals 

Inc./Wockhardt USA LLC. 

ANDA 084041 ................................. Chlordiazepoxide HCl Capsules, 10 mg ............................................... Upsher-Smith Laboratories, LLC, 

6701 Evenstad Dr., Maple 

Grove, MN 55369. 

ANDA 084678 ................................. Chlordiazepoxide HCl Capsules, 5 mg ................................................. Do. 

ANDA 084679 ................................. Chlordiazepoxide HCl Capsules, 25 mg ............................................... Do. 

ANDA 088508 ................................. Homatropine Methylbromide; Hydrocodone Bitartrate Tablets, 1.5 mg; 

5 mg.

King Pharmaceuticals Research 

and Development, LLC, 4000 

Centregreen Way, Suite 300, 

Cary, NC 27513. 

ANDA 089953 ................................. Thioridazine HCl Tablets, 10 mg, 25 mg, 50 mg, and 100 mg ............ Sun Pharmaceutical Industries, 

Inc., 2 Independence Way, 

Princeton, NJ 08540. 

ANDA 090094 ................................. Didanosine Delayed Release Capsules, 125 mg, 200 mg, 250 mg, 

and 400 mg.

Aurobindo Pharma USA, Inc., 279 

Princeton-Hightstown Rd., East 

Windsor, NJ 08520. 

ANDA 090394 ................................. Iopamidol Injection, 61% and 76% ........................................................ Sanochemia Corporation USA, 

9201 University City Blvd., c/o 

Countervail Corp., Charlotte, NC 

08876. 

ANDA 091302 ................................. Fludrocortisone Acetate Tablets, 0.1 mg .............................................. Hikma Pharmaceuticals USA Inc., 

1809 Wilson Rd., Columbus, OH 

43228. 

ANDA 203959 ................................. Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, and 250 

mg.

Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of 

Teva Pharmaceuticals USA, 

Inc.), 425 Privet Rd., Horsham, 

PA 19044. 

ANDA 204243 ................................. Indomethacin Extended Release Capsules, 75 mg .............................. Aurobindo Pharma USA, Inc. 

ANDA 206061 ................................. Pravastatin Sodium Tablets, 20 mg, 40 mg, and 80 mg ...................... Hisun Pharmaceuticals USA, Inc., 

200 Crossing Blvd., 2nd Floor, 

Bridgewater, NJ 08807. 

ANDA 206857 ................................. Tiagabine HCl Tablets, 2 mg, 4 mg, 12 mg, and 16 mg ...................... Wilshire Pharmaceuticals, Inc., 6 

Concourse Pkwy., Suite 1800, 

Atlanta, GA 30328. 

ANDA 209076 ................................. Ibuprofen Tablets, 200 mg .................................................................... Ultra Tab Laboratories, Inc., 50 

Toc Dr., Highland, NY 12528. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 16, 

2021. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on February 16, 

2021 may continue to be dispensed 

until the inventories have been depleted 

or the drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4083 

1E.g., 85 FR 75893 (Nov. 27, 2020). 

2 Drug Amendments of 1962, Pub. L. 87–781, 76 

Stat. 780 (Oct. 10, 1962). 

3 1962 U.S.C.C.A.N. 2884, 2891. 

4Proceedings, FDA Conference on the KefauverHarris Drug Amendments and Proposed 

Regulations, at 7 (Feb. 15, 1963). 

5 Id. at 6. 

6 Drug Price Competition and Patent Term 

Restoration Act of 1984, Public Law 98–417, 98 

Stat. 1585, 1588 (Sept. 24, 1984). 

7 GAO, FDA Drug Approval, Application Review 

Times Largely Reflect Agency Goals (Mar. 2020), 

https://www.gao.gov/assets/710/705193.pdf. 

8FDA, New Drug Therapy Approvals 2019, 

https://www.fda.gov/drugs/new-drugs-fda-cdersnew-molecular-entities-and-new-therapeuticbiological-products/new-drug-therapy-approvals2019. 

9 In its review, the Department obtained the 

‘‘submission date’’ (or, if available, ‘‘filing date’’) of 

the 48 drugs by searching documents available to 

the public on FDA’s Drugs@FDA website. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00833 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

FDA Drug Review Timeline 

Transparency; Statement of Policy 

The Department and its component 

agencies exist to serve the American 

people. Consistent with and in follow 

up to the Department’s previous 

transparency efforts,1 and given the 

significant impact FDA’s approval of 

drugs has on Americans, the Secretary 

believes the public would benefit from 

information regarding the timeline for 

FDA’s review of drug product 

applications as provided in this 

document. 

In 1962, Congress amended the Food, 

Drug, and Cosmetic Act (FD&C Act) to 

authorize the Food and Drug 

Administration (FDA) to review and 

approve ‘‘new drugs’’ for safety and 

efficacy.2 When Congress made this 

historic change to our nation’s drug 

laws, it provided a timeframe for FDA’s 

review. In section 104 of the Drug 

Amendments of 1962, codified at 

section 505(c) of the FD&C Act, 21 

U.S.C. 355(c), Congress required that, 

for New Drug Applications (NDAs), 

‘‘[w]ithin one hundred eighty days after 

the filing of an application . . . , the 

Secretary shall either approve the 

application . . . or give the applicant 

notice of an opportunity for a hearing 

before the Secretary.’’ As the Senate 

Judiciary Committee explained at the 

time, ‘‘this provision strikes a balance 

between the need for governmental 

control to assure that new drugs are not 

placed on the market until they have 

passed the relevant tests and the need 

to insure that governmental control does 

not become so rigid that the flow of new 

drugs to the market, and the incentive 

to undergo the expense involved in 

preparing them for the market, become 

stifled.’’ 3

At the time, the 180-day timeframe for 

review of ‘‘new drugs’’ was 

uncontroversial. At a 1963 public 

hearing, the Acting Director for FDA’s 

Division of New Drugs stated that 

‘‘[a]pplications for drugs of questionable 

safety or effectiveness will continue to 

take more of every body’s time.’’ 4

However, the Director ‘‘pledge[d] action 

greatly short of the 180-day limit on all 

applications and supplements that 

present good scientific evidence of the 

safety and effectiveness of the drugs and 

that are properly informative to the 

physician or patient.’’ 5

When Congress made additional 

amendments to the FD&C Act in 1984, 

it borrowed from and applied the 

existing 180-day review framework to 

the review of Abbreviated New Drug 

Applications (ANDAs), the approval 

mechanism for generic drugs.6 Under 

section 505(j)(5)(A) of the FD&C Act, 21 

U.S.C. 355(j)(5)(A), the Secretary ‘‘shall 

approve or disapprove the [ANDA] 

application’’ ‘‘[w]ithin one hundred and 

eighty days of the initial receipt of an 

application.’’ FDA promulgated 

regulations implementing the 180-day 

statutory provisions for review of NDAs 

and ANDAs. See 21 CFR 314.100, 

314.101. While the Prescription Drug 

User Fee Act (PDUFA) and Generic Drug 

User Fee Act (GDUFA) in their iterative 

forms have provided FDA with 

additional resources to carry out its 

statutory mission, Congress did not do 

away with the 180-day provisions in 

section 505 of the FD&C Act, 21 U.S.C. 

355, in those laws. 

Though the agency has made strides 

over the years to expedite review in the 

face of limited resources, the total time 

elapsed between FDA’s filing of an NDA 

or receipt of an ANDA to ultimate 

approval or disapproval of the 

application often exceeds 180 days. 

Even so, reporting on drug approvals, 

such as GAO’s March 2020 report,7

focused primarily on agency compliance 

with PDUFA dates. The GAO report did 

not mention the 180-day benchmark or 

discuss the agency’s approval timeframe 

in view of that requirement. 

Given this gap in reporting, the 

Department reviewed FDA’s New Drug 

Therapy Approvals from 2019 8 in view 

of the 180-day timeframe. The 

Department’s review considered 48 

products listed by the agency as 

approved in 2019.9 The table below 

presents, among other things, the date of 

submission, date of approval, total days 

from submission to approval, and total 

days in excess of 180 days of 

submission for these drugs. 

Drug brand name Summary of FDA-approved use on approval 

date 

Submission 

date Approval date 

Days 

submission 

to approval 

Days in 

excess of 

180 days 

Accrufer ......................... Iron deficiency anemia ......................................... 9/27/2018 7/25/2019 301 121 

Adakveo ........................ Reduce vasoocclusive crises in sickle cell disease.5/16/2019 11/15/2019 183 3 

Aklief .............................. Acne vulgaris ....................................................... 10/4/2018 10/4/2019 365 185 

Balversa ........................ Locally advanced or metastatic bladder cancer .. 9/18/2018 4/12/2019 206 26 

Beovu ............................ Wet age-related macular degeneration ............... 2/7/2019 10/7/2019 242 62 

Brukinsa ........................ Mantle cell lymphoma .......................................... 6/27/2019 11/14/2019 140 N/A 

Cablivi ............................ Acquired thrombotic thrombocytopenic purpura .. 6/6/2018 2/6/2019 245 65 

Caplyta .......................... Schizophrenia ...................................................... 9/27/2018 12/20/2019 449 269 

Dayvigo ......................... Insomnia ............................................................... 12/27/2018 12/20/2019 358 178 

Egaten ........................... Fascioliasis ........................................................... 6/14/2018 2/13/2019 244 64 

Enhertu .......................... Metastatic breast cancer ...................................... 8/29/2019 12/20/2019 113 N/A 

Evenity ........................... Osteoporosis ........................................................ 7/9/2018 4/9/2019 274 94 

ExEm Foam .................. Diagnostic agent for fallopian tube assessment .. 10/9/2018 11/7/2019 394 214 

Fetroja ........................... Complicated urinary tract infection ...................... 12/14/2018 11/14/2019 335 155 

fluorodopa F 18 ............. Diagnostic agent for Parkinsonian syndromes .... 4/10/2019 10/10/2019 183 3