[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27440-27441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0162]


Determination That NORMODYNE (Labetalol Hydrochloride) Injection, 
5 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of 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 Agency) has 
determined that NORMODYNE (labetalol hydrochloride) injection, 5 
milligrams per milliliter (mg/mL), was not withdrawn from sale for 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: Christopher Koepke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3600, 
Christopher.Koepke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
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)).

[[Page 27441]]

FDA may not approve an ANDA that does not refer to a listed drug.
    NORMODYNE (labetalol hydrochloride) injection, 5 mg/mL, is the 
subject of NDA 018686, held by Schering Corp., and initially approved 
on August 1, 1984. NORMODYNE is indicated for control of blood pressure 
in severe hypertension.
    In a letter dated September 28, 2004, Schering Corp. notified FDA 
that NORMODYNE (labetalol hydrochloride) injection, 5 mg/mL, was being 
discontinued and requested withdrawal of NDA 018686 for NORMODYNE 
(labetalol hydrochloride), and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book. In the 
Federal Register of June 16, 2006 (71 FR 34940), FDA announced that it 
was withdrawing approval of NDA 018686, effective June 16, 2006.
    Nexsen Pruet, LLC, submitted a citizen petition dated February 4, 
2021 (Docket No. FDA-2021-P-0162), under 21 CFR 10.30, requesting that 
the Agency determine whether NORMODYNE (labetalol hydrochloride) 
injection, 5 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 NORMODYNE (labetalol hydrochloride) injection, 
5 mg/mL, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
this drug product was withdrawn for reasons of safety or effectiveness. 
We have carefully reviewed our files for records concerning the 
withdrawal NORMODYNE (labetalol hydrochloride) injection, 5 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 NORMODYNE (labetalol 
hydrochloride) injection, 5 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: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10594 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P


