Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3877 

TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued 

Application No. Drug Applicant 

ANDA 207919 .... Acyclovir Sodium injectable, EQ 50 mg base/mL ................... Dr. Reddy’s Laboratories Inc., 107 College Rd. East, Princeton, NJ 08540. 

ANDA 209325 .... Miglustat capsule, 100 mg ....................................................... Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 

201, Berlin, CT 06037. 

ANDA 209708 .... Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 

mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/ 

mL).

Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite 

A, Wixom, MI 48393. 

ANDA 211893 .... Ranitidine HCl capsule, EQ 150 mg base and EQ 300 mg 

base.

Appco Pharma LLC, 262 Old New Brunswick Rd., Suite M, 

N, B–1, F, Piscataway, NJ 08854. 

ANDA 214428 .... Niacin extended-release tablet, 500 mg and 1 g .................... Sciecure Pharma Inc., U.S. Agent for Beijing Sciecure Pharmaceutical Co., Ltd., 138 Glendale Ave., Edison, NJ 

08817. 

ANDA 215908 .... Nitisinone capsule, 2 mg, 5 mg, 10 mg, and 20 mg ............... Torrent Pharma Inc., 106 Allen Rd., Suite 305, Basking 

Ridge, NJ 07920. 

ANDA 217094 .... Fluphenazine HCl tablet, 1 mg, 2.5 mg, 5 mg, and 10 mg ..... Torrent Pharma Inc., U.S. Agent for Torrent Pharmaceuticals 

Ltd., 106 Allen Rd., Suite 305, Basking Ridge, NJ 07920. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 14, 

2025. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from table 1. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in table 1 without an approved 

new drug application or ANDA 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 

are listed in table 1 that are in inventory 

on February 14, 2025 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 8, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00742 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5851] 

Teva Branded Pharmaceutical 

Products R&D, Inc., et al.; Withdrawal 

of Approval of 12 New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 12 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 

February 14, 2025. 

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. 

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 009388 .......... Diamox IV (acetazolamide) Injectable, Equivalent to (EQ) 

500 milligrams (mg) base per vial.

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

Brandywine Parkway, West Chester, PA 19380. 

NDA 012836 .......... Persantine (dipyridamole) Tablets, 25mg, 50mg, and 75mg Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury 

Road, P.O. Box 368, Ridgefield, CT 06877. 

NDA 018817 .......... Calan (verapamil hydrochloride (HCl)) Tablets, 40 mg, 80 

mg, 120 mg, and 160 mg.

Pfizer Inc., 66 Hudson Boulevard East, New York, NY 

10001. 

NDA 021743 .......... Tarceva (erlotinib HCl) Tablets, EQ 25 mg base, EQ 100 

mg base, and EQ 150 mg base.

OSI Pharmaceuticals, LLC, 2375 Waterview Dr., Northbrook, IL 60062. 

NDA 021785 .......... Invirase (saquinavir mesylate) Tablets, EQ 500 mg base ..... Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, 

South San Francisco, CA 94080. 

NDA 021937 .......... Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Tablets, 600 mg/200 mg/300 mg.Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 

94404. 

NDA 022383 .......... Arcapta Neohaler (indacaterol maleate) Powder for Inhalation, EQ 75 micrograms base.Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936. 

NDA 204412 .......... Delzicol (mesalamine), Delayed-Release Capsules, 400 mg AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064. 

NDA 210875 .......... Kynmobi (apomorphine HCl) Sublingual Film, 10 mg, 15 

mg, 20 mg, 25 mg, and 30 mg.

Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752. 


lotter on DSK11XQN23PROD with NOTICES1
3878 Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 

TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued 

Application No. Drug Applicant 

NDA 211172 .......... Tegsedi (inotersen sodium) Solution for Injection, EQ 284 

mg base/1.5 mL.

Akcea Therapeutics, Inc., 2850 Gazelle Ct., Carlsbad, CA 

92010. 

NDA 212640 .......... Exservan (riluzole) Oral Film, 50 mg ..................................... Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 

07059. 

NDA 213426 .......... Seglentis (celecoxib and tramadol HCl) 56 mg; 44 mg ......... Kowa Pharmaceuticals America, Inc., 530 Industrial Park 

Blvd., Montgomery, AL 36117. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 14, 

2025. 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 

are listed in table 1 that are in inventory 

on February 14, 2025 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 6, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00743 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5716] 

High-Protein Yogurt; Request for 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

requesting information and data about 

the manufacturing processes and 

ingredients used to make certain dairy 

products referred to as high-protein 

yogurt, Greek yogurt, or Greek-style 

yogurt in this document. We are taking 

this action, in part, because the yogurt 

standard of identity may not align with 

certain manufacturing processes and 

ingredients used to concentrate protein 

to manufacture these products. We 

intend to use the information and data 

to help determine what type(s) of 

actions, if any, should be taken. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by April 15, 2025. 

ADDRESSES: You may submit comments 

and information as follows. Please note 

that late, untimely filed comments will 

not be considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 15, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–5716 for ‘‘High-Protein Yogurt; 

Request for Information.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://


lotter on DSK11XQN23PROD with NOTICES1