[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Page 21891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07942]



[[Page 21891]]

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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Injection, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of 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.

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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milligrams (mg), was not withdrawn from sale for reasons of safety or 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, [email protected].

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 (Sec.  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 Sec.  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


