Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83973 

meaningfully reduce abuse and declined 

the company’s request to include 

labeling describing potentially abusedeterrent properties for OPANA ER. 

Based on postmarketing data, FDA 

later observed that there was a 

significant shift in the route of abuse 

from nasal to injection following the 

product’s reformulation. Injection abuse 

of reformulated OPANA ER has been 

associated with a serious outbreak of 

HIV and hepatitis C, as well as cases of 

a serious blood disorder (thrombotic 

microangiopathy). On June 8, 2017, FDA 

requested that Endo remove 

reformulated OPANA ER from the 

market based on its concern that the 

benefits of the drug may no longer 

outweigh its risks due to the public 

health consequences of abuse (see 

https://www.fda.gov/news-events/pressannouncements/fda-requests-removalopana-er-risks-related-abuse). On July 6, 

2017, Endo announced it would 

voluntarily remove reformulated 

OPANA ER from the market. 

On October 3, 2017, Endo requested 

withdrawal of NDA 201655 for 

reformulated OPANA ER under 

§ 314.150(d) (21 CFR 314.150(d)) and 

waived its opportunity for a hearing. For 

the reasons discussed above, and 

pursuant to the applicant’s request, 

approval of NDA 201655 for 

reformulated OPANA ER (oxymorphone 

hydrochloride) extended-release tablets, 

and all amendments and supplements 

thereto, is withdrawn under 

§ 314.150(d). Distribution of 

reformulated OPANA ER into interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(a) and 

331(d)). 

Dated: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28283 Filed 12–22–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2272] 

Hospira, Inc., et al.; Withdrawal of 

Approval of 27 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 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applications be withdrawn.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 

January 22, 2021. 

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. 

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 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 

NDA 008809 ............. M.V.I.-12 Adult (ascorbic acid, biotin, cyanocobalamin, dexpanthenol, 

ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride (HCl), riboflavin 5’-phosphate sodium, thiamine HCl, vitamin A, and vitamin E) Injection, 10 milligrams (mg)/milliliters (mL), 0.006 mg/mL, 0.5 micrograms (mcg)/ 

mL, 1.5 mg/mL, 20 International Units (IU)/mL, 0.04 mg/mL, 4 mg/mL, 0.4 

mg/mL, 0.36 mg/mL, 0.3 mg/mL, 330 Units/mL, and 1 IU/mL; and 20 mg/mL, 

0.006 mg/mL, 0.05 mcg/mL, 1.5 mg/mL, 0.0005 mg/mL, 0.06 mg/mL, 4 mg/ 

mL, 0.6 mg/mL, 0.36 mg/mL, 0.6 mg/mL, 0.1 mg/mL, and 1 mg/mL.

M.V.I.-12 Adult (ascorbic acid, biotin, cyanocobalamin, dexpanthenol, 

ergocalciferol, folic acid, niacinamide, pyridoxine HCl, riboflavin, thiamine 

HCl, vitamin A, and vitamin E) Injection, 20 mg/mL, 0.006 mg/mL, 0.5 mcg/ 

mL, 1.5 mg/mL, 20 IU/mL, 0.6 mg/mL, 4 mg/mL, 0.4 mg/mL, 0.36 mg/mL, 

0.6 mg/mL, 330 Units/mL, and 1 IU/mL..

Hospira, Inc., 275 North Field Dr., Lake 

Forest, IL 60045. 

NDA 017673 ............. Aminosyn (amino acids) Injection, 5% (5 grams (g)/100 mL), 7% (7 g/100 mL), 

7% (pH6) (7 g/100 mL), 8.5% (8.5 g/100 mL), 8.5% (pH6) (8.5 g/100 mL), 

10% (10 g/100 mL), and 10% (pH6) (10 g/100 mL).

Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic) Injection, 

8.5% (8.5 g/100mL), 102 mg/100 mL, 487 mg/100 mL, 28 mg/100 mL, and 

425 mg/100 mL..

Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride) Injection, 8.5% (8.5 g/100 

mL), 102 mg/100 mL, 522 mg/100 mL, and 410 mg/100 mL..

ICU Medical, Inc., 600 North Field Dr., 

Lake Forest, IL 60045. 

NDA 017735 ............. Modicon 28 (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/0.5 mg ..... Janssen Pharmaceuticals, Inc., 1125 

Trenton-Harbourton Rd., Titusville, 

NJ 08560. 

NDA 017743 ............. Brevicon 28-Day (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/0.5 

mg.

Allergan Sales, LLC, 5 Giralda Farms, 

Madison, NJ 07940. 

NDA 017789 ............. Aminosyn 3.5% (amino acids) Injection, 3.5% (3.5 g/100 mL).

Aminosyn 3.5% M (amino acids, magnesium acetate, phosphoric acid, potassium acetate, and sodium chloride) Injection, 3.5% (3.5 g/100 mL), 21 mg/ 

100 mL, 40 mg/100 mL, 128 mg/100 mL, and 234 mg/100 mL..

Aminosyn 3.5% M (amino acids, magnesium acetate, potassium acetate, and 

sodium chloride) Injection, 3.5% (3.5 g/100 mL), 21 mg/100 mL, 128 mg/100 

mL, and 234 mg/100 mL..


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83974 Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 

Application No. Drug Applicant 

Aminosyn 7% With Electrolytes (amino acids, magnesium chloride, potassium 

phosphate dibasic, and sodium chloride) Injection, 7% (7 g/100 mL), 102 

mg/100 mL, 410 mg/100 mL, and 522 mg/100 mL..

ICU Medical, Inc. 

NDA 018069 ............. Vansil (oxamniquine) Capsules, 250 mg .............................................................. Pfizer, Inc., 235 East 42nd St., New 

York, NY 10017. 

NDA 018081 ............. Depakene (valproic acid) Capsules, 250 mg ....................................................... AbbVie, Inc., 1 North Waukegan Rd., 

North Chicago, IL 60064. 

NDA 018281 ............. Tegretol (carbamazepine) Chewable Tablets, 100 mg ........................................ Novartis Pharmaceuticals Corp., 1 

Health Plaza, East Hanover, NJ 

07936. 

NDA 018429 ............. Aminosyn-RF 5.2% (amino acids) Injection, 5.2% (5.2 g/100 mL). ..................... ICU Medical, Inc. 

NDA 018704 ............. Lopressor (metoprolol tartrate) Injection, 1 mg/mL .............................................. Novartis Pharmaceuticals Corp. 

NDA 018876 ............. Potassium Chloride 5 milliequivalent (mEq) in Dextrose 5% and Sodium Chloride 0.3% in Plastic Container (dextrose, potassium chloride, and sodium 

chloride) Injection, 5 g/100 mL, 74.5 mg/100 mL, and 300 mg/100 mL.

Potassium Chloride 5 mEq in Dextrose 5% and Sodium Chloride 0.3% in Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 

g/100 mL, 149 mg/100 mL, and 300 mg/100 mL..

Potassium Chloride 10 mEq in Dextrose 5% and Sodium Chloride 0.3% in 

Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 74.5 mg/100 mL, and 300 mg/mL..

Potassium Chloride 10 mEq in Dextrose 5% and Sodium Chloride 0.3% in 

Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 149 mg/100 mL, and 300 mg/mL..

Potassium Chloride 15 mEq in Dextrose 5% and Sodium Chloride 0.3% in 

Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 224 mg/100 mL, and 300 mg/100 mL..

Potassium Chloride 20 mEq in Dextrose 5% and Sodium Chloride 0.3% in 

Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 298 mg/100 mL, and 300 mg/100 mL..

Potassium Chloride 20 mEq in Dextrose 5% in Sodium Chloride 0.3% in Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 

g/100 mL, 149 mg/100 mL, and 300 mg/100 mL..

Potassium Chloride 30 mEq in Dextrose 5% and Sodium Chloride 0.3% in 

Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 224 mg/100 mL, and 300 mg/100 mL..

Potassium Chloride 40 mEq in Dextrose 5% and Sodium Chloride 0.3% in 

Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 298 mg/100 mL, and 300 mg/100 mL..

Do. 

NDA 018985 ............. Ortho Novum 7/7/7 (ethinyl estradiol and norethindrone) (White) Tablets, 0.035 

mg ethinyl estradiol and 0.5 mg norethindrone, (Light Peach) Tablets, 0.035 

mg ethinyl estradiol and 0.75 mg norethindrone, (Peach) Tablets, 0.035 mg 

ethinyl estradiol and 1 mg norethindrone.

Janssen Pharmaceuticals, Inc. 

NDA 019029 ............. Metronidazole Tablets, 250 mg ............................................................................ LNK International, Inc., 145 Ricefield 

Lane, Hauppauge, NY 11788. 

NDA 019374 ............. Aminosyn-HBC 7% (amino acids) Injection, 7% (7 g/100 mL). ........................... ICU Medical, Inc. 

NDA 019435 ............. Nix (permethrin) Topical Lotion, 1% ..................................................................... GlaxoSmithKline Consumer Healthcare 

Holdings (US) LLC, 184 Liberty Corner Rd., suite 2000, Warren, NJ 

07059. 

NDA 019437 ............. Aminosyn II M (amino acids, magnesium chloride, potassium chloride, sodium 

chloride, and sodium phosphate dibasic heptahydrate) Injection, 3.5% (3.5 g/ 

100 mL), 30 mg/100 mL, 97 mg/100 mL, 120 mg/100 mL, and 49 mg/100 

mL.

Aminosyn II With Electrolytes (amino acids, magnesium chloride, potassium 

chloride, potassium phosphate dibasic, and sodium chloride) Injection, 7% (7 

g/100 mL), 102 mg/100 mL, 45 mg/100 mL, 522 mg/100 mL, and 410 mg/ 

100 mL; 8.5% (8.5 g/100 mL), 102 mg/100 mL, 45 mg/100 mL, 522 mg/100 

mL, and 410 mg/100 mL; and 10% (10 g/100 mL), 102 mg/100 mL, 45 mg/ 

100 mL, 522 mg/100 mL, and 410 mg/100 mL..

Aminosyn II With Electrolytes (amino acids, magnesium chloride, potassium 

chloride, sodium chloride, and sodium phosphate dibasic) Injection, 8.5% 

(8.5 g/100 mL), 102 mg/100 mL, 492 mg/100 mL, 60 mg/100 mL, and 425 

mg/100 mL..

Do. 

NDA 019438 ............. Aminosyn II 3.5% (amino acids) Injection, 3.5% (3.5 g/100 mL).

Aminosyn II 5% (amino acids) Injection, 5% (5 g/100 mL).

Aminosyn II 7% (amino acids) Injection, 7% (7 g/100 mL)..

Aminosyn II 8.5% (amino acids) Injection, 8.5% (8.5 g/100 mL)..

Aminosyn II 10% (amino acids) Injection, 10% (10 g/100 mL). ........................... Do. 

NDA 019653 ............. Ortho-Cyclen-21 (ethinyl estradiol and norgestimate) Oral-21 Tablets, 0.035 

mg/0.250 mg.

Ortho Cyclen-28 (ethinyl estradiol and norgestimate) Oral-28 Tablets, 0.035 

mg/0.25 mg..

Janssen Pharmaceuticals, Inc. 

NDA 019894 ............. Dextrose 50% in Plastic Container (dextrose) Injection, 50 g/100 mL ................ ICU Medical, Inc. 


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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83975 

Application No. Drug Applicant 

NDA 019916 ............. Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL ............................................. Do. 

NDA 020593 ............. Depacon (valproate sodium) Injection, Equivalent to (EQ) 100 mg base/mL ...... AbbVie, Inc. 

NDA 020634 ............. Levaquin (levofloxacin) Tablets, 250 mg, 500 mg, and 750 mg .......................... Janssen Pharmaceuticals, Inc. 

NDA 021241 ............. Ortho Tri-Cyclen Lo (ethinyl estradiol and norgestimate) Oral-28 (White) Tablets, 0.025 mg ethinyl estradiol and 0.18 mg norgestimate; (Light Blue) Tablets, 0.025 mg ethinyl estradiol and 0.215 mg norgestimate; (Dark Blue) Tablets, 0.025 mg ethinyl estradiol and 0.250 mg norgestimate.Do. 

NDA 206544 ............. MorphaBond ER (morphine sulfate) Extended-Release Tablets, 15 mg, 30 mg, 

60 mg, and 100 mg.

Daiichi Sankyo, Inc., 211 Mount Airy 

Rd., Basking Ridge, NJ 07920. 

NDA 208399 ............. Varubi (rolapitant HCl) Injectable Emulsion, EQ 166.5 mg base/92.5 mL (EQ 

1.8 mg base/mL).

TerSera Therapeutics LLC, 520 Lake 

Cook Rd., suite 500, Deerfield, IL 

60015. 

NDA 209203 ............. Duzallo (allopurinol and lesinurad) Tablets, 200 mg/200 mg and 300 mg/200 

mg.

Ironwood Pharmaceuticals, Inc., 100 

Summer St., suite 2300, Boston, MA 

02110. 

NDA 210895 ............. Welchol (colesevelam HCl) Chewable Bars, 3.75 g ............................................ Daiichi Sankyo, Inc. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 22, 

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 January 22, 

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. 

Dated: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28346 Filed 12–22–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Extension of Designation of Scarce 

Materials or Threatened Materials 

Subject to COVID–19 Hoarding 

Prevention Measures; Correction of 

Extension Date 

AGENCY: Office of the Secretary (OS), 

DHHS. 

ACTION: Correction. 

SUMMARY: This document updates the 

July 30, 2020, Federal Register Notice 

entitled ‘‘Extension of Designation of 

Scarce Materials or Threatened 

Materials Subject to COVID–19 

Hoarding Prevention Measures,’’ by 

revising the last sentence in the 

‘‘Summary’’ section. 

FOR FURTHER INFORMATION CONTACT: 

Paige Ezernack, Office of the Assistant 

Secretary for Preparedness and 

Response, Office of Strategy, Policy, 

Planning, and Requirements, Suite 

5440—O’Neill House Office Building, 

200 C Street SW, Washington, DC 

20201, (202) 260–0365. 

SUPPLEMENTARY INFORMATION: 

I. Correction of Errors 

In FR Doc. 2020–16458 of July 30, 

2020 (85 FR 45895–45897), make the 

following corrections: 

On page 48596, first full column, 

SUMMARY section, change second to last 

sentence to ‘‘This notice, issued on July 

23, 2020, extends the March 25 

Designation Notice to January 19, 2021.’’ 

The expiration date, January 19, 2021 is 

not 120 days from the date of issuance 

so remove that reference. 

Wilma Robinson, 

Deputy Executive Secretary, Department of 

Health and Human Services. 

[FR Doc. 2020–28374 Filed 12–22–20; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; 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 National Advisory Dental 

and Craniofacial Research Council. 

The meeting will be open to the 

public via NIH videocast. The URL link 

to this meeting is https:// 

videocast.nih.gov/watch=38984. 

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: National Advisory 

Dental and Craniofacial Research Council. 

Date: January 27, 2021. 

Open: 10:00 a.m. to 1:05 p.m. 

Agenda: Report of the Director, NIDCR 

Place: National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

662 Bethesda, MD 20892, (Virtual Meeting). 

Closed: 1:20 p.m. to 2:00 p.m. 

Agenda: Grant applications. 

Place: National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

662 Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Alicia J. Dombroski, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health, 6701 

Democracy Boulevard, Room 662, Bethesda, 

MD 20892, 301–594–4805, adombroski@

nidcr.nih.gov. 

Any interested person may file written 

comments with the committee no later than 

15 days after the meeting by forwarding the 

statement to the Contact Person listed on this 

notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcr.nih.gov/about, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 


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