25028 Federal Register / Vol. 87, No. 81 / Wednesday, April 27, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0412] 

Determination That FOLVITE (Folic 

Acid), Oral Tablets, 1 Milligram, and 

Other Drug Products, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (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in this document were not withdrawn 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: 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 generally known 

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the listed drug was withdrawn from sale 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 005897 .......... FOLVITE ........................... Folic Acid .......................... 1 Milligram (mg) ................ Tablet; Oral ....................... Wyeth Ayerst Pharms. 

NDA 005897 .......... FOLVITE ........................... Folic Acid .......................... 5 mg/Milliliter (mL) ............ Injectable; Injection ........... Wyeth Ayerst Pharms. 

NDA 014691 .......... ALKERAN ......................... Melphalan .......................... 2 mg .................................. Tablet; Oral ....................... Apotex Inc. 

NDA 015923 .......... HALDOL ............................ Haloperidol Lactate ........... Equivalent to (EQ) 5 mg 

Base/mL.

Injectable; Injection ........... Janssen Pharms. 

NDA 016042 .......... DYAZIDE ........................... Hydrochlorothiazide; 

Triamterene.

25 mg; 50 mg, 25 mg; 

37.5 mg.

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

NDA 017959 .......... ADRUCIL .......................... Fluorouracil ....................... 50 mg/mL .......................... Injectable; Injection ........... Pharmacia & Upjohn Co. 

NDA 017993 .......... HYDERGINE ..................... Ergoloid Mesylates ............ 0.5 mg, 1 mg ..................... Tablet; Oral ....................... Novartis AG. 

NDA 018082 .......... DEPAKENE ....................... Valproic Acid ..................... 250 mg/5 mL ..................... Syrup; Oral ........................ AbbVie Inc. 

NDA 018116 .......... CYCLOCORT .................... Amcinonide ....................... 0.025%, 0.1% .................... Cream; Topical .................. Astellas. 

NDA 018498 .......... CYCLOCORT .................... Amcinonide ....................... 0.1% .................................. Ointment; Topical .............. Astellas. 

NDA 018985 .......... ORTHO–NOVUM 7/7/7 ..... Ethinyl Estradiol; 

Norethindrone.

0.035 mg; 0.5 mg, 0.035 

mg; 0.75 mg, 0.035 mg; 

1 mg.

Tablet; Oral ....................... Janssen Pharms. 

NDA 019297 .......... NOVANTRONE ................. Mitoxantrone Hydrochloride.EQ 20 mg Base/10 mL, 

EQ 2 mg Base/mL.

Injectable; Injection ........... EMD Serono Inc. 

NDA 019927 .......... NIZORAL ........................... Ketoconazole .................... 2% ..................................... Shampoo; Topical ............. Janssen Pharms. 

NDA 020207 .......... ALKERAN ......................... Melphalan Hydrochloride .. EQ 50 mg Base/Vial ......... Injectable; Injection ........... Apotex Inc. 

NDA 020262 .......... TAXOL .............................. Paclitaxel ........................... 6 mg/mL ............................ Injectable; Injection ........... HQ Specialty Pharma. 

NDA 020281 .......... ULTRAM ........................... Tramadol Hydrochloride .... 100 mg .............................. Tablet; Oral ....................... Janssen Pharms. 

NDA 021692 .......... ULTRAM ER ..................... Tramadol Hydrochloride .... 100 mg, 200 mg, 300 mg Tablet, Extended Release; 

Oral.

Valeant Pharms. 

NDA 021844 .......... DESONATE ...................... Desonide ........................... 0.05% ................................ Gel; Topical ....................... Leo Pharma. 

NDA 022008 .......... REQUIP XL ....................... Ropinirole Hydrochloride ... EQ 2 mg Base, EQ 4 mg 

Base, EQ 6 mg Base, 

EQ 8 mg Base, EQ 12 

mg Base.

Tablet, Extended Release; 

Oral.

GlaxoSmithKline LLC. 

NDA 050639 .......... CLEOCIN PHOSPHATE 

IN DEXTROSE 5% IN 

PLASTIC CONTAINER.

Clindamycin Phosphate .... EQ 6 mg Base/mL, EQ 12 

mg Base/mL, EQ 18 mg 

Base/mL.

Injectable; Injection ........... Pfizer. 

NDA 050684 .......... ZOSYN .............................. Piperacillin Sodium; 

Tazobactam Sodium.

EQ 2 g Base/Vial; EQ 250 

mg Base/Vial, EQ 3 g 

Base/Vial; EQ 375 mg 

Base/Vial, EQ 4 g Base/ 

Vial; EQ 500 mg Base/ 

Vial, EQ 36 g Base/Vial; 

EQ 4.5 g Base/Vial.

Injectable; Injection ........... Wyeth Ayerst Pharms. 

ANDA 062336 ....... MUTAMYCIN .................... Mitomycin .......................... 40 mg/Vial ......................... Injectable; Injection ........... Bristol-Myers Squibb. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 81 / Wednesday, April 27, 2022 / Notices 25029 

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 

drug products listed are unaffected by 

the discontinued marketing of the 

products subject to these applications. 

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: April 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08940 Filed 4–26–22; 8:45 am] 

BILLING CODE 4164–01–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: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Neuroscience of 

Basic Visual Processes Study Section. 

Date: June 8–9, 2022. 

Time: 10:00 a.m. to 4:00 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: Kirk Thompson, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5184, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1242, kgt@mail.nih.gov. 

Name of Committee: Vascular and 

Hematology Integrated Review Group; Basic 

Biology of Blood, Heart and Vasculature 

Study Section. 

Date: June 16–17, 2022. 

Time: 9:00 a.m. to 9:00 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: Katherine M. Malinda, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

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

0912, malindakm@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 22, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–08958 Filed 4–26–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: NIGMS Initial Review 

Group; Training and Workforce Development 

Study Section–D; Review of IMSD and PREP 

Applications. 

Date: June 16–17, 2022. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of General 

Medical Science, Natcher Bldg. 45, 45 Center 

Drive, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Tracy Koretsky, Ph.D., 

Scientific Review Officer, National Institute 

of General Medical Sciences, National 

Institutes of Health, 45 Center Drive, MSC 

6200, Room 3An.12F, Bethesda, MD 20892, 

301 594 2886, tracy.koretsky@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.859, 

Biomedical Research and Research Training, 

National Institutes of Health, HHS) 

Dated: April 22, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–08968 Filed 4–26–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center 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 Fogarty International 

Center Advisory Board. 

The meeting will be open to the 

public via online meeting. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

Contact Person listed below in advance 

of the meeting. 

The meeting 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: Fogarty International 

Center Advisory Board. 

Date: June 6–7, 2022. 

Closed: June 6, 2022, 1:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate the 

second level of grant applications. 

Place: Fogarty International Center, 

National Institutes of Health, 31 Center Drive, 

Room B2C02, Bethesda, MD 20892 (Virtual 

Meeting). 

Open: June 7, 2022, 12:00 p.m. to 3:00 p.m. 


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