5828 Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices 

Application No. Drug Applicant 

NDA 020037 ........................ Voltaren (diclofenac sodium) Ophthalmic Solution, 0.1% Novartis Pharmaceuticals Corp., 1 Health Plaza, East 

Hanover, NJ 07936–1080. 

NDA 021169 ........................ Razadyne (galantamine hydrobromide) Tablets, EQ 4 

mg base, EQ 8 mg base, and EQ 12 mg base.

Janssen Research & Development, LLC, 1125 TrentonHarbourton Rd., Titusville, NJ 08560. 

NDA 021204 ........................ Starlix (nateglinide) Tablets, 60 mg, and 120 mg .......... Novartis Pharmaceuticals Corp. 

NDA 021406 ........................ Fortical (calcitonin-salmon recombinant) Nasal Spray, 

200 International Units/Spray.

Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., 

Maple Grove, MN 55369. 

NDA 021860 ........................ Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ 

15 mg base, and EQ 20 mg base.

Allergan Pharmaceuticals International Ltd., c/o 

Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 

07940. 

NDA 202833 ........................ Picato (ingenol mebutate) Gel, 0.015%, and 0.05% ...... LEO Laboratories Ltd., c/o LEO Pharma Inc., 7 Giralda 

Farms, Madison, NJ 07940. 

NDA 202880 ........................ Zohydro ER (hydrocodone bitartrate) Extended-release 

Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 

50 mg.

Recro Gainesville LLC, 1300 Gould Dr., Gainesville, 

GA 30504. 

NDA 204683 ........................ Khedezla (desvenlafaxine) Extended-Release Tablets, 

50 mg, and 100 mg.

Osmotica Pharmaceutical US LLC, 400 Crossing Blvd., 

Bridgewater, NJ 08807. 

NDA 207916 ........................ Cetylev (acetylcysteine) Effervescent Tablets, 500 mg, 

and 2.5 g.

Arbor Pharmaceuticals, LLC, 6 Concourse Pkwy., Suite 

1800, Atlanta, GA 30328. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of March 4, 

2022. 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application is withdrawn, including any 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 March 4, 2022 

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: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02059 Filed 2–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0074] 

Watson Laboratories, Inc., et al.; 

Withdrawal of Approval of Eight 

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 eight 

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 

March 4, 2022. 

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 075152 ........ Diclofenac Potassium Tablets, 50 milligrams (mg) ................ Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Bldg. A, Parsippany, NJ 07054. 

ANDA 091376 ........ Topotecan Hydrochloride (HCl) for Injection, Equivalent to 

(EQ) 4 mg base/vial.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. 

ANDA 091471 ........ Efavirenz Tablets, 600 mg ..................................................... Mylan Pharmaceuticals Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. 

ANDA 200463 ........ Itraconazole Capsules, 100 mg ............................................. Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504. 

ANDA 202395 ........ Ziprasidone HCl Capsules, EQ 20 mg base, EQ 40 mg 

base, EQ 60 mg base, and EQ 80 mg base.

Do. 

ANDA 203170 ........ Docetaxel Injection, 40 mg/milliliter ........................................ Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, 

eVenus Pharmaceutical Laboratories Inc., 506 Carnegie 

Center, Suite 100, Princeton, NJ 08540. 

ANDA 203574 ........ Mesalamine Delayed Release Tablets, 1.2 grams ................ Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504. 

ANDA 208177 ........ Atazanavir Sulfate Capsules, EQ 150 mg base, EQ 200 mg 

base, and EQ 300 mg base.

Do. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices 5829 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of March 4, 

2022. 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 March 4, 2022 

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: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02053 Filed 2–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Literature Selection 

Technical Review Committee. 

The meeting is devoted to the review 

and evaluation of journals for potential 

indexing by the National Library of 

Medicine and will be closed to the 

public in accordance with the 

provisions set forth in section 

552b(c)(9)(B), Title 5 U.S.C., as 

amended. Premature disclosure of the 

titles of the journals as potential titles to 

be indexed by the National Library of 

Medicine, the discussions, and the 

presence of individuals associated with 

these publications could significantly 

frustrate the review and evaluation of 

individual journals. 

Name of Committee: Literature Selection 

Technical Review Committee. 

Date: June 23–24, 2022. 

Time: 9:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate journals 

as potential titles to be indexed by the 

National Library of Medicine. 

Place: Virtual Meeting. 

Contact Person: Dianne Babski, Associate 

Director, Division of Library Operations, 

National Library of Medicine, 8600 Rockville 

Pike, Building 38, Room 4S404, Bethesda, 

MD 20894, 301–827–4729, babskid@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS). 

Dated: January 28, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–02128 Filed 2–1–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Imaging Guided 

Interventions and Surgery Study Section. 

Date: March 3–4, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Yuanna Cheng, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1195, Chengy5@csr.nih.gov. 

Name of Committee: Biology of 

Development and Aging Integrated Review 

Group; Drug Discovery and Molecular 

Pharmacology Study Section. 

Date: March 3–4, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jeffrey Smiley, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6194, 

MSC 7804, Bethesda, MD 20892, 301–594– 

7945, smileyja@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Chemistry, Biochemistry and 

Biophysics A. 

Date: March 3, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Shan Wang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 496–4390, shan.wang@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Hypersensitivity, Allergies and Mucosal 

Immunology (HAMI). 

Date: March 3–4, 2022. 

Time: 9:30 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Deborah Hodge, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4207, 

MSC 7812, Bethesda, MD 20892, (301) 435– 

1238, hodged@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; AREA/ 

REAP: Cardiovascular and Respiratory 

Sciences. 

Date: March 3, 2022. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Sara Ahlgren, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, RM 4136, 

Bethesda, MD 20892, 301–435–0904, 

sara.ahlgren@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Antiviral 

Drug Discovery and Mechanisms of 

Resistance. 

Date: March 7–8, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Shinako Takada, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–402–9448, shinako.takada@

nih.gov. 

Name of Committee: Population Sciences 

and Epidemiology Integrated Review Group; 

Infectious Diseases, Reproductive Health, 

Asthma and Pulmonary Conditions Study 

Section. 

Date: March 7–8, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


jspears on DSK121TN23PROD with NOTICES1