Notice2024-19233
Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
August 27, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) has determined that DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/ mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diltiazem HCl, 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 89 Issue 166 (Tuesday, August 27, 2024)</title>
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[Federal Register Volume 89, Number 166 (Tuesday, August 27, 2024)]
[Notices]
[Pages 68624-68625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19233]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-1131]
Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
(Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/
Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/
Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or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 or the Agency) has
determined that DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem
hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for diltiazem HCl,
125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Neerja Razdan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#91dff4f4e3fbf0bfc3f0ebf5f0ffd1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="89c7ececfbe3e8a7dbe8f3ede8e7c9efede8a7e1e1faa7eee6ff">[email protected]</span></a>.
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
[[Page 68625]]
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 (Sec. 314.162 (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.
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125
mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), is the subject of NDA 215252,
held by Exela Pharma Sciences, LLC, and initially approved on October
28, 2021. DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% is indicated for the
following: (1) temporary control of rapid ventricular rate in atrial
fibrillation or atrial flutter; and (2) rapid conversion of paroxysmal
supraventricular tachycardias to sinus rhythm.
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125
mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book. In
previous instances (see, e.g., 72 FR 9763 (March 5, 2007), 61 FR 25497
(May 21, 1996)), the Agency has determined that, for purposes of
Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
Fresenius Kabi USA, LLC submitted a citizen petition dated March 5,
2024 (Docket No. FDA-2024-P-1131), under 21 CFR 10.30, requesting that
the Agency determine whether DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL),
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 DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL),
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125 mL
(1 mg/mL) and 250 mg/250 mL (1 mg/mL), was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL
(1 mg/mL), from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that this drug product
was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125 mL (1 mg/mL)
and 250 mg/250 mL (1 mg/mL), 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: August 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19233 Filed 8-26-24; 8:45 am]
BILLING CODE 4164-01-P
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