41322 Federal Register / Vol. 87, No. 132 / Tuesday, July 12, 2022 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–14758 Filed 7–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–1349] 

Mikart, LLC, et al.; Withdrawal of 

Approval of 31 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 31 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applications be withdrawn. 

DATES: Approval is withdrawn as of 

August 11, 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 040846 ............... Hydrocodone Bitartrate and Acetaminophen Tablets, 325 milligrams 

(mg); 2.5 mg.

Mikart, LLC, 1750 Chattahoochee Ave. NW, 

Atlanta, GA 30318. 

ANDA 040851 ............... Benzonatate Capsules, 100 mg, 150 mg, and 200 mg ........................ Do. 

ANDA 072903 ............... Ibuprofen Tablets, 200 mg .................................................................... ANI Pharmaceuticals, Inc., 210 Main St. 

West, Baudette, MN 56623. 

ANDA 073519 ............... Tolmetin Sodium Capsules, Equivalent to (EQ) 400 mg base ............. Do. 

ANDA 074267 ............... Guanabenz Acetate Tablets, EQ 4 mg base and EQ 8 mg base ........ Do. 

ANDA 074498 ............... Indapamide Tablets, 1.25 mg and 2.5 mg ............................................ Do. 

ANDA 074840 ............... Etodolac Capsules, 200 mg and 300 mg ............................................. Do. 

ANDA 074844 ............... Etodolac Capsules, 200 mg and 300 mg ............................................. Do. 

ANDA 075212 ............... Ranitidine Hydrochloride (HCl) Tablets, EQ 75 mg base ..................... Do. 

ANDA 076030 ............... Flecainide Acetate Tablets, 50 mg, 100 mg, and 150 mg ................... Do. 

ANDA 076086 ............... Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg ............... Do. 

ANDA 077426 ............... Ranitidine HCl Tablets, EQ 150 mg base and EQ 300 mg base ......... Do. 

ANDA 077641 ............... Zonisamide Capsules, 25 mg, 50 mg, and 100 mg ............................. Do. 

ANDA 077979 ............... Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg, and 3 

mg.

Do. 

ANDA 085269 ............... Meclizine HCl Tablets, 12.5 mg ............................................................ Do. 

ANDA 085740 ............... Meclizine HCI Tablets, 25 mg ............................................................... Do. 

ANDA 087296 ............... Chlorthalidone Tablets, 25 mg .............................................................. Do. 

ANDA 088164 ............... Chlorthalidone Tablets, 25 mg .............................................................. Do. 

ANDA 088641 ............... Glucamide Tablets, 250 mg .................................................................. Do. 

ANDA 088732 ............... Meclizine HCl Tablets, 12.5 mg ............................................................ Do. 

ANDA 088768 ............... Chlorpropamide Tablets, 100 mg ......................................................... Do. 

ANDA 088826 ............... Chlorpropamide Tablets, 250 mg ......................................................... Do. 

ANDA 090572 ............... Cetirizine HCl, Syrup 5 mg/5 milliliters (mL) ......................................... Tris Pharma, Inc., 2031 U.S. Hwy. 130, Suite 

D, Monmouth Junction, NJ 08852. 

ANDA 090906 ............... Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1 gram (gm) .. Alvogen PB Research and Development, U.S. 

Agency for Lotus Pharmaceutical Co., Ltd., 

Nantou Plant, 44 Whippany Rd., Suite 300, 

Morristown, NJ 07960. 

ANDA 201944 ............... Potassium Chloride Extended Release Capsules, 8 milliequivalent 

(mEq) and 10 mEq.

Tris Pharma, Inc. 

ANDA 202095 ............... Levetiracetam Extended Release Tablets, 500 mg and 750 mg ......... Alvogen PB Research and Development, U.S. 

Agency for Lotus Pharmaceutical Co., Ltd. 

ANDA 202246 ............... Levonorgestrel Tablets, 1.5 mg ............................................................ Alvogen, Inc., 44 Whippany Rd., Suite 300, 

Morristown, NJ 07960. 

ANDA 203298 ............... Calcium Acetate Capsules, 667 mg ...................................................... Alvogen PB Research and Development, U.S. 

Agency for Lotus Pharmaceutical Co., Ltd. 

ANDA 204180 ............... Amiloride HCl Tablets, 5 mg ................................................................. USpharma Windlas, LLC, 115 Blue Jay Dr., 

Suite 101, Liberty, MO 64068. 

ANDA 205442 ............... Linezolid Injection, 600 mg/300 mL (2 mg/mL) .................................... Hospira, Inc., 275 North Field Dr., Bldg. H1, 

Lake Forest, IL 60045. 

ANDA 205790 ............... Prasugrel Tablets, EQ 5 mg base and EQ 10 mg base ...................... USpharma Windlas, LLC. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of August 11, 

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 


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Federal Register / Vol. 87, No. 132 / Tuesday, July 12, 2022 / Notices 41323 

(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 August 11, 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: July 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14798 Filed 7–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1729] 

Revocation of Emergency Use of a 

Drug During the COVID–19 Pandemic; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to Fresenius Kabi USA, LLC 

(Fresenius Kabi), for Fresenius 

Propoven 2% Emulsion. FDA revoked 

the Authorization on May 10, 2022, 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). The 

revocation, which includes an 

explanation of the reasons for the 

revocation, is reprinted in this 

document. 

DATES: The Authorization is revoked as 

of May 10, 2022. 

ADDRESSES: Submit written requests for 

single copies of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

Authorizations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the Authorizations. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

301–796–8510 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On May 8, 

2020, FDA issued an Authorization 

(EUA 050) to Fresenius Kabi for 

Fresenius Propoven 2% Emulsion, 

subject to the terms of the 

Authorization. Notice of the issuance of 

the Authorization was published in the 

Federal Register on September 11, 2020 

(85 FR 56231), as required by section 

564(h)(1) of the FD&C Act. The 

authorization of a drug for emergency 

use under section 564 of the FD&C Act 

may, pursuant to section 564(g)(2) of the 

FD&C Act, be revoked when the criteria 

under section 564(c) of the FD&C Act for 

issuance of such authorization are no 

longer met (section 564(g)(2)(B) of the 

FD&C Act), or other circumstances make 

such revocation appropriate to protect 

the public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. EUA Revocation Request 

In a request received by FDA on April 

8, 2022, Fresenius Kabi requested 

revocation of, and on May 10, 2022, 

FDA revoked, the Authorization for the 

Fresenius Propoven 2% Emulsion. 

Because Fresenius Kabi notified FDA 

that it does not intend to offer the 

Fresenius Propoven 2% Emulsion in the 

United States anymore and requested 

FDA revoke the EUA for the Fresenius 

Propoven 2% Emulsion, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocation is available on the internet at 

https://www.regulations.gov/. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA for 

Fresenius Kabi’s Fresenius Propoven 

2% Emulsion. The revocation in its 

entirety follows and provides an 

explanation of the reasons for 

revocation, as required by section 

564(h)(1) of the FD&C Act. 


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