[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30320-30321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11802]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-2317]


Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine 
Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/
Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale 
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride) 
Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 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was not withdrawn from sale for reasons of safety or effectiveness.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 QUELICIN PRESERVATIVE FREE (succinylcholine 
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [email protected].

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)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 
mg/mL, 50 mg/mL, and 100 mg/mL, is the subject of NDA 008845, held by 
Hospira, Inc., and initially approved on May 1, 1953. QUELICIN 
PRESERVATIVE FREE is indicated as an adjunct to general anesthesia, to 
facilitate tracheal intubation, and to provide skeletal muscle 
relaxation during surgery or mechanical ventilation.
    Baxter Healthcare Corp. submitted a citizen petition dated December 
21, 2020 (Docket No. FDA-2020-P-2317), under 21 CFR 10.30, requesting 
that the Agency determine whether QUELICIN PRESERVATIVE FREE 
(succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 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 QUELICIN PRESERVATIVE FREE (succinylcholine 
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was not 
withdrawn for reasons of safety or

[[Page 30321]]

effectiveness. The petitioner has identified no data or other 
information suggesting that QUELICIN PRESERVATIVE FREE (succinylcholine 
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of QUELICIN PRESERVATIVE 
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 
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 QUELICIN PRESERVATIVE 
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 
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. ANDAs that refer to 
QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/
mL, 50 mg/mL, and 100 mg/mL, may 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 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11802 Filed 6-4-21; 8:45 am]
BILLING CODE 4164-01-P