[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Injection, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of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milligrams (mg), was not withdrawn from sale for reasons of safety or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