Federal Register / Vol. 87, No. 71 / Wednesday, April 13, 2022 / Notices 21891 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–1354] 

Determination That TOTECT 

(Dexrazoxane Hydrochloride) for 

Injection, 500 Milligrams, Was 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Withdrawn From Sale for Reasons of 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, Agency, or we) 

has determined that TOTECT 

(dexrazoxane hydrochloride) for 

injection, 500 milligrams (mg), was 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withdrawn from sale for reasons of 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 this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product, as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Sungjoon Chi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6216, 

Silver Spring, MD 20993–0002, 240– 

402–9674, Sungjoon.Chi@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 known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are 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the listed drug was withdrawn from sale 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). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

TOTECT (dexrazoxane hydrochloride) 

for injection, 500 mg, is the subject of 

NDA 022025, held by Clinigen, Inc., and 

initially approved on September 6, 

2007. TOTECT is a cytoprotective agent 

indicated for the treatment of 

extravasation resulting from intravenous 

anthracycline chemotherapy and for 

reducing the incidence and severity of 

cardiomyopathy associated with 

doxorubicin administration in women 

with metastatic breast cancer who have 

received a cumulative doxorubicin dose 

of 300 mg/square meter and who will 

continue to receive doxorubicin therapy 

to maintain tumor control. 

In a letter dated May 11, 2021, 

Clinigen, Inc., notified FDA that 

TOTECT (dexrazoxane hydrochloride) 

for injection, 500 mg, was being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the ‘‘Orange 

Book.’’ 

Cardinal Health Regulatory Sciences 

submitted a citizen petition dated 

December 23, 2021 (Docket No. FDA– 

2021–P–1354), under 21 CFR 10.30, 

requesting that the Agency determine 

whether TOTECT (dexrazoxane 

hydrochloride) for injection, 500 mg, 

was withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that TOTECT (dexrazoxane 

hydrochloride) for injection, 500 mg, 

was not withdrawn for reasons of safety 

or effectiveness. The petitioner has 

identified no data or other information 

suggesting that TOTECT (dexrazoxane 

hydrochloride) for injection, 500 mg, 

was withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of TOTECT 

(dexrazoxane hydrochloride) for 

injection, 500 mg, from sale. We have 

also independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list TOTECT (dexrazoxane 

hydrochloride) for injection, 500 mg, in 

the ‘‘Discontinued Drug Product List’’ 

section of the ‘‘Orange Book.’’ The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: April 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07942 Filed 4–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Amended Notice of 

Meeting 

Notice is hereby given of a change in 

the meeting of the National Advisory 

Council on Alcohol Abuse and 

Alcoholism, May 10, 2022, 11:00 a.m. to 

May 11, 2022, 3:00 p.m., National 

Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20817, which was 

published in the Federal Register on 

March 30, 2022, FR Doc. No. 2022– 

06714, 87 FR 18374. 

This notice is being amended to 

change the start and end times of the 

open session on May 10, 2022, from 

12:45 p.m. to 12:30 p.m. and from 5:00 

p.m. to 5:30 p.m. As such the May 10, 

2022, open session will now be held 

from 12:30 p.m. to 5:30 p.m. The 

meeting is partially closed to the public. 

Dated: April 8, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–07910 Filed 4–12–22; 8:45 am] 

BILLING CODE 4140–01–P 


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