[Federal Register Volume 89, Number 166 (Tuesday, August 27, 2024)]
[Notices]
[Pages 68624-68625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or 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mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for 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, 
[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

[[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