75002 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: October 27, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24123 Filed 10–31–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4319] 

Determination That CALCIUM 

DISODIUM VERSENATE (Edetate 

Calcium Disodium) Injection, 200 

Milligrams per Milliliter, and Other 

Drug Products Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

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in this document were not withdrawn 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 008922 .... CALCIUM DISODIUM 

VERSENATE.

Edetate Calcium Disodium.200 Milligrams (mg)/Milliliter (mL) ..... Injectable; Injection ........ Bausch Health US, LLC. 

NDA 011722 .... TENUATE ...................... Diethylpropion Hydrochloride.25 mg ................................................. Tablet; Oral .................... Nostrum Labs., Inc. 

NDA 012546 .... TENUATE DOSPAN ...... Diethylpropion Hydrochloride.75 mg ................................................. Tablets, Extended-Release; Oral.Do. 

NDA 019117 .... FLUOCINONIDE ............ Fluocinonide .................. 0.05% ................................................. Cream; Topical .............. Taro Pharms. U.S.A., 

Inc. 

NDA 019796 .... ELOCON ........................ Mometasone Furoate .... 0.1% ................................................... Lotion; Topical ............... Organon, LLC. 

NDA 020489 .... ANDRODERM ............... Testosterone .................. 2 mg/24 hours; 4 mg/24 hours .......... Film, Extended Release; 

Transdermal.

AbbVie Inc. 

NDA 020884 .... AGGRENOX ................... Aspirin; Dipyridamole ..... 25 mg; 200 mg .................................. Capsule, Extended Release; Oral.Boehringer Ingelheim 

Pharms., Inc. 

NDA 020903 .... REBETOL ...................... Ribavirin ......................... 200 mg ............................................... Capsule; Oral ................. Merck Sharp and Dohme 

Corp. 

NDA 020907 .... ACTIVELLA ................... Estradiol; Norethindrone 

Acetate.

0.5 mg; 0.1 mg .................................. Tablet; Oral .................... Amneal Pharms., LLC. 

NDA 020949 .... ACCUNEB ..................... Albuterol Sulfate ............ Equivalent to (EQ) 0.021% Base; EQ 

0.042% Base.

Solution; Inhalation ........ Mylan Specialty LP. 

NDA 021022 .... PENLAC ........................ Ciclopirox ....................... 8% ...................................................... Solution; Topical ............ Valeant International 

Bermuda. 

NDA 021449 .... HEPSERA ...................... Adefovir Dipivoxil ........... 10 mg ................................................. Tablet; Oral .................... Gilead Sciences, Inc. 

NDA 022052 .... ZYFLO CR ..................... Zileuton .......................... 600 mg ............................................... Tablet, Extended Release; Oral.Chiesi USA, Inc. 

NDA 022511 .... VIMOVO ........................ Esomeprazole Magnesium; Naproxen.EQ 20 mg Base; 375 mg; EQ 20 mg 

Base; 500 mg.

Tablet, Delayed Release; Oral.Horizon Medicines LLC. 

NDA 022569 .... LAZANDA ...................... Fentanyl Citrate ............. EQ 0.1mg Base; EQ 0.3 mg Base; 

EQ 0.4 mg Base.

Spray, Metered; Nasal ... BTcP Pharma, LLC. 

NDA 202788 .... SUBSYS ........................ Fentanyl ......................... 0.1 mg; 0.2 mg; 0.4 mg; 0.6 mg; 0.8 

mg; 1.2 mg; 1.6 mg.

Spray; Sublingual .......... Do. 

NDA 213645 .... DAPZURA RT ................ Daptomycin .................... 500 mg/Vial ........................................ Powder; Intravenous ...... Baxter Healthcare Corp. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 75003 

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: October 27, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24120 Filed 10–31–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–E–3178] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Omegaven 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Omegaven and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by January 2, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

April 29, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 2, 

2024. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of January 2, 2024.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– 

2019–E–3178 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; OMEGAVEN.’’ 

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.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its 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 § 10.20 (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://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 


ddrumheller on DSK120RN23PROD with NOTICES1