91410 Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–P–3482] 

Determination That JESDUVROQ 

(daprodustat) Tablets, 1 Milligram, 2 

Milligrams, 4 Milligrams, 6 Milligrams, 

and 8 Milligrams, Were Not Withdrawn 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, Agency, or we) 

has determined that JESDUVROQ 

(daprodustat) tablets, 1 milligram (mg), 

2 mg, 4 mg, 6 mg, and 8 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for JESDUVROQ 

(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 

6 mg, and 8 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: Awo 

Archampong-Gray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6243, 

Silver Spring, MD 20993–0002, 301– 

796–0110, Awo.Archampong-Gray@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

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the listed drug was withdrawn from sale 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. 

JESDUVROQ (daprodustat) tablets, 1 

mg, 2 mg, 4 mg, 6 mg, and 8 mg, are the 

subject of NDA 216951, held by 

GlaxoSmithKline Intellectual Property 

(No. 2) Limited England, and initially 

approved on February 1, 2023. 

JESDUVROQ is a hypoxia-inducible 

factor prolyl hydroxylase (HIF PH) 

inhibitor indicated for the treatment of 

anemia due to chronic kidney disease in 

adults who have been receiving dialysis 

for at least 4 months. JESDUVROQ 

(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 

6 mg, and 8 mg, are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Qilu Pharmaceutical (Hainan) Co., 

Ltd., submitted a citizen petition dated 

July 24, 2024 (Docket No. FDA–2024–P– 

3482), under 21 CFR 10.30, requesting 

that the Agency determine whether 

JESDUVROQ (daprodustat) tablets, 1 

mg, 2 mg, 4 mg, 6 mg, and 8 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 JESDUVROQ 

(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 

6 mg, and 8 mg, were not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that 

JESDUVROQ (daprodustat) tablets, 1 

mg, 2 mg, 4 mg, 6 mg, and 8 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

JESDUVROQ (daprodustat) tablets, 1 

mg, 2 mg, 4 mg, 6 mg, and 8 mg, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list JESDUVROQ 

(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 

6 mg, and 8 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 JESDUVROQ 

(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 

6 mg, or 8 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 this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26915 Filed 11–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4860] 

Pfizer, Inc., et al.; Withdrawal of 

Approval of 26 New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 26 new drug 

applications (NDAs) 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 

December 19, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in table 1 have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 91411 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Drug Applicant 

NDA 012541 ........ Depo-Provera (medroxyprogesterone acetate) Injectable, 

100 milligrams (mg)/milliliter (mL) and 400 mg/mL.

Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. 

NDA 012945 ........ Diamox (acetazolamide) Extended-Release Capsules, 500 

mg.

Teva Branded Pharmaceutical Products R&D, Inc., 145 

Brandywine Parkway, West Chester, PA 19380. 

NDA 013132 ........ Deca-Durabolin (nandrolone decanoate) Injectable, 50 mg/ 

mL,100 mg/mL, and 200 mg/mL.

Woodward Specialty, LLC, 16825 West 116th St., Lenexa, 

KS 66219. 

NDA 018063 ........ Corgard (nadolol) Tablets, 20 mg, 40 mg, 80 mg, 120 mg, 

and 160 mg.

USWM, LLC, 4441 Springdale Rd., Louisville, KY 40241. 

NDA 019950 ........ Diflucan in Dextrose 5% in Plastic Container (fluconazole), 

Injectable, 200 mg/100 mL and 400 mg/200 mL.

Diflucan in Sodium Chloride 0.9% (fluconazole), Injectable, 

200 mg/100 mL and 400 mg/200 mL.

Diflucan in Sodium Chloride 0.9% in Plastic Container 

(fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 

mL.

Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. 

NDA 020001 ........ Capex (fluocinolone acetonide) Shampoo, 0.01% .................. Galderma Laboratories, L.P., 2001 Ross Ave., Suite 1600, 

Dallas, TX 75201. 

NDA 020938 ........ Mobic (meloxicam) Tablets, 7.5 mg and 15 mg ..................... Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury 

Rd., Ridgefield, CT 06877. 

NDA 021333 ........ Minirin (desmopressin acetate) Metered Nasal Spray, 0.01 

mg/spray.

Ferring Pharmaceuticals Inc., 100 Interpace Parkway, Parsippany, NJ 07054. 

NDA 021372 ........ Aloxi (palonosetron hydrochloride (HCl)) Injectable, Equivalent to (EQ) 0.075 mg base/1.5 mL and EQ 0.25 mg base/ 

5 mL.

Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc., 

200 Wood Ave. South, Suite 100, Iselin, New Jersey 

08830. 

NDA 021689 ........ Nexium IV (esomeprazole sodium) Injectable, EQ 20 mg 

base/vial and EQ 40mg base/vial.

AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803. 

NDA 021861 ........ Patanase (olopatadine HCl) Metered Nasal Spray, 0.665 

mg/spray.

Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936. 

NDA 022025 ........ Totect (dexrazoxane HCl) Injectable, EQ 500 mg base/vial .. Clinigen, Inc., 45 Great Valley Parkway, Malvern, PA 19355. 

NDA 022204 ........ Gelnique (oxybutynin chloride) Transdermal Gel, 10% (100 

mg/packet).

AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 

60064. 

NDA 022233 ........ Aloxi (palonosetron HCl) Capsules, EQ 0.5 mg base ............ Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc. 

NDA 022502 ........ Differin (adapalene) Lotion, 0.1% ........................................... Galderma Laboratories. 

NDA 022524 ........ Zuplenz (ondansetron) Oral Film, 4 mg and 8 mg ................. Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 

07059. 

NDA 050297 ........ Ery-Ped (erythromycin ethylsuccinate) Chewable Tablets, 

EQ 200 mg base.

E.E.S. (erythromycin ethylsuccinate) Chewable Tablets, EQ 

200 mg base.

Azurity Pharmaceuticals, Inc., 8 Cabot Rd., Woburn, MA 

01801. 

NDA 050611 ........ PCE (erythromycin) Coated Particles in Tablets, 333 mg and 

500 mg.

Do. 

NDA 050824 ........ Omeclamox-Pak (amoxicillin Capsules, 500 mg; 

clarithromycin Tablets, 500 mg; and omeprazole DelayedRelease Capsules, 20 mg).

Cumberland Pharmaceuticals Inc., 1600 West End Ave., 

Suite 1300, Nashville, TN 37203. 

NDA 203667 ........ Minastrin 24 Fe (ethinyl estradiol/norethindrone acetate) 

Tablets, 0.02 mg/1 mg.

Allergan Pharmaceuticals International Ltd. c/o AbbVie Inc., 

1 N Waukegan Rd., North Chicago, IL 60064. 

NDA 204427 ........ Kerydin (tavabarole) Topical Solution, 5% .............................. Anacor Pharmaceuticals Inc., 445 Eastern Point Rd., Groton, CT 06340. 

NDA 205103 ........ Yosprala (aspirin/omeprazole) Delayed-Release Tablets, 81 

mg/40 mg and 325 mg/40 mg.

Genus Lifesciences Inc., 514 North 12th St., Allentown, PA 

18102. 

NDA 205383 ........ Oraltag (iohexol) for Oral Solution, 9.7 gram/bottle ................ Interpharma Praha AS c/o Otsuka Pharmaceutical Development and Commercialization Inc., 508 Carnegie Center 

Dr., Princeton, NJ 08540. 

NDA 207930 ........ Utibron (glycopyrrolate, indacaterol maleate) Inhalation Powder, 15.6 microgram/inhaler and 27.5 microgram/inhaler.Novartis Pharmaceuticals Corp. 

NDA 207923 ........ Seebri Neohaler (glycopyrrolate) Inhalation Powder, 15.6 

microgram/inhaler.

Do. 

NDA 216951 ........ Jesduvroq (daprodustat) Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 

and 8 mg.

GlaxoSmithKline Intellectual Property (No. 2) Ltd. England 

c/o GSK, 2929 Walnut St., Suite 1700, Philadelphia, PA 

19104. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of December 19, 

2024. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms included in 

the application but inadvertently 

missing from table 1. Introduction or 

delivery for introduction into interstate 

commerce of products listed in table 1 

without an approved NDA violates 

sections 505(a) and 301(d) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). Drug products that 


ddrumheller on DSK120RN23PROD with NOTICES1
91412 Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 

are listed in table 1 that are in inventory 

on December 19, 2024 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. 

Dated: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26913 Filed 11–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Rural Health Care Services 

Outreach Program Measures 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than December 19, 

2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Rural Health Care Services Outreach 

Program Measures, OMB No. 0906– 

0009—Revision. 

Abstract: The Rural Health Care 

Services Outreach Program is 

authorized by section 330A(e) of the 

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

254c(e)) to ‘‘promote rural health care 

services outreach by improving and 

expanding the delivery of health care 

services to include new and enhanced 

services in rural areas.’’ The goals for 

the Rural Health Care Services Outreach 

Program are as follows: (1) expand the 

delivery of health care services in rural 

communities; (2) deliver health care 

services through a strong consortium, in 

which every consortium member 

organization is actively involved and 

engaged in the planning and delivery of 

services; (3) utilize and/or adapt an 

evidence-based or innovative, evidenceinformed model(s) in the delivery of 

health care services; and (4) improve 

population health and demonstrate 

health outcomes and sustainability. 

HRSA collects information from grant 

recipients that participate in this 

program using an OMB-approved set of 

performance measures and seeks to 

extend its approved information 

collection. 

A 60-day notice was published in the 

Federal Register on June 21, 2024, 89 

FR 52069–70. There were no public 

comments. However, following 

publication of the 60-day notice, HRSA 

increased the average burden per 

response and total burden hours due to 

personnel changes resulting in training 

needs of new hires common among 

rural healthcare workforce in the 

Outreach Program. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were drafted to 

provide data to the program and to 

enable HRSA to provide aggregate 

program data required by Congress 

under the Government Performance and 

Results Act of 1993. These measures 

cover the principal topic areas of 

interest to the Federal Office of Rural 

Health Policy (FORHP), including: (1) 

access to care, (2) population 

demographics, (3) consortium/network, 

(4) sustainability, (5) project specific 

domains, and (6) clinical measures. All 

measures will speak to FORHP’s 

progress toward meeting the goals set. 

FORHP collects this information to 

quantify the impact of grant funding on 

access to health care, quality of services, 

and improvement of health outcomes. 

FORHP uses the data for program 

improvement and grantees use the data 

for performance tracking. No 

substantive changes are proposed from 

the current data collection effort; 

FORHP proposes updating hyperlinks 

for the clinical measures and including 

an option for text entry to capture 

names of counties for the number of 

counties served measure. 

Likely Respondents: The respondents 

would be recipients of the Rural Health 

Care Services Outreach Program grants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Rural Health Care Services Outreach Performance Measures ................................................................................... 61 1 61 8 488 

Total .............................................................................. 61 ........................ 61 ........................ 488 


ddrumheller on DSK120RN23PROD with NOTICES1